IVY BIOMEDICAL SYSTEMS, INC.

Address:11 BUSINESS PARK DR.,Branford,CT,06405,US

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Filters

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

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) (DRT) (8) Cable, Transducer And Electrode, Patient, (Including Connector) (DSA) (1) Electrode, Electrocardiograph (DRX) (1)

Premarket Exempt

No Yes

Clear

Model 7600 - 00816396022249 Catalog Number : 3303-45-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

ECG Patient Cable - 00816396022294 Catalog Number :

Device Description : ECG Patient Cable, Shielded, 3 Lead, AHA-IEC, 1.5M

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Model 7700 - 00816396022331 Catalog Number : 3607-04-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : No

Device Count : 1

ECG Lead Wires - 00816396022348 Catalog Number : 590319

Device Description : ECG Lead Wires, Radiotranslucent, 3 Lead Set, AHA, 36 in

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRX

Prescription Use : No

Device Count : 1

Model 7800 - 00816396022355 Catalog Number : 3300-23-15

Device Description : Cardiac Gating Module

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : No

Device Count : 1

Model 7800 - 00816396022362 Catalog Number : 3304-36-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

Model 7800 - 00816396022379 Catalog Number : 3304-37-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

Model 7800 - 00816396022386 Catalog Number : 3304-38-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

Model 7800 - 00816396022393 Catalog Number : 3300-24-15

Device Description : Cardiac Gating Module

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

Model 7800 - 00816396022409 Catalog Number : 3300-25-15

Device Description : Cardiac Gating Module

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

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