MIDMARK CORPORATION

Address:5171 California Ave,Irvine,CA,92617,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Unit, X-Ray, Extraoral With Timer (EHD) (5) Electrocardiograph, Ambulatory, With Analysis Algorithm (MLO) (4) Electrocardiograph (DPS) (1)

Premarket Exempt

No Yes

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Midmark PREVA IntraOral Dental X-ray System - 00841709100536 Catalog Number : P7017-P

Device Description : Intraoral X-ray

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Midmark PREVA IntraOral Dental X-ray System - 00841709100543 Catalog Number : P7018-P

Device Description : Intraoral X-ray

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Midmark PREVA IntraOral Dental X-ray System - 00841709100550 Catalog Number : P7017GM

Device Description : Intraoral X-ray

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Midmark PREVA 2.0 IntraOral Dental X-ray System - 00841709100567 Catalog Number : DCD5-W2B

Device Description : Intraoral X-ray

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Midmark PREVA 2.0 IntraOral Dental X-ray System - 00841709100574 Catalog Number : DCD5-W2M/H

Device Description : Intraoral X-ray

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Midmark IQecg® Digital ECG - 00841709100581 Catalog Number : 1-100-1330

Device Description : The IQecg® from Midmark is an easy-to-use, digital, 12-lead resting ECG solution The IQecg® from Midmark is an easy-to-use, digital, 12-lead resting ECG solution that helps you quickly administer testing and access patient test results you need to make informed cardiac assessments and provide more efficient patient care.

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Midmark IQholter Digital Holter - 00841709100598 Catalog Number : 4-000-0110

Device Description : The Midmark IQholter system combines a compact digital recorder with three power The Midmark IQholter system combines a compact digital recorder with three powerful software applications. Easy-to-use Holter software with fully automated analysis and reporting, designed for routine monitoring situations in fast-paced offices. Kit includes: Midmark IQholter Recorder (includes lead wire set, secure digital card), Reusable IQholter Recorder Pouch and Belt, Secure Digital Card Reader, Software Security Key USB Version, and Holter Prep Kits.

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

Midmark IQholter EX Digital Holter - 00841709100604 Catalog Number : 4-000-0113

Device Description : The Midmark IQholter EX system combines a compact digital recorder with three po The Midmark IQholter EX system combines a compact digital recorder with three powerful software applications. Includes the standard features of IQholter with expanded functionality for A-Fib, QT/QTc and HRV analysis, template editing, Smart Page Scan and more. Kit includes: Midmark IQholter Recorder (includes lead wire set, secure digital card), Reusable IQholter Recorder pouch and Belt, Secure Digital Card Reader, Software Security Key, USB Version, and Holter Prep Kits.

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

Midmark IQholter® EP Digital Holter - 00841709100611 Catalog Number : 4-000-0116

Device Description : The Midmark IQholter® EP system combines a compact digital recorder with three p The Midmark IQholter® EP system combines a compact digital recorder with three powerful software applications. Includes all the features of IQholter® EX plus Pacemaker detection of single and dual-chamber paced beats for non-captures and sensing failures.situations in fast-paced offices. Kit includes: Midmark IQholter EP with Pacemaker Detection, Midmark IQholter Recorder (includes Lead Wire Set, Secure Digital Card), Reusable IQholter Recorder Pouch and Belt, Secure Digital Card Reader, Software Security Key, USB Version, and Holter Prep Kits.

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

Midmark IQholter® Digital Holter Recorder Kit - 00841709100628 Catalog Number : 4-000-0119

Device Description : Small and lightweight digital Holter recorder. Standard 24-hour recording with Small and lightweight digital Holter recorder. Standard 24-hour recording with 48 and 72-hour recording capabilities available. Midmark IQHolter Recorder, Lead wire set, Secure Digital Card, Four Holter Prep Kits, and Reusable IQholter Recorder Pouch and Belt.

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

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