CARDIAC INSIGHT, INC.

Address:2375 130th Ave NE,Bellevue,WA,98005,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

Computer, Diagnostic, Programmable (DQK) (5) Recorder, Magnetic Tape, Medical (DSH) (5) Electrocardiograph (DPS) (1)

Premarket Exempt

No Yes

Clear

CardeaScreen - 00857553006009 Catalog Number : CS-2020-A

Device Description : CardeaScreen is a portable ECG recorder designed for collection of resting (non- CardeaScreen is a portable ECG recorder designed for collection of resting (non-ambulatory) ECG data with software used for subsequent analysis of the patient's ECG data.

Device Class : 2

Duns Number: 827419834

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Stealth System S300 - 00857553006092 Catalog Number : C300/D300

Device Description : StealthView Software & Smart Cable - ECG analysis software (D300) and data trans StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300).

Device Class :

Duns Number: 827419834

Premarket Exempt : No

Product Code : DQK, DSH

Prescription Use : Yes

Device Count : 1

Cardea SOLO - 00857553006139 Catalog Number : D300

Device Description : Cardea SOLO PC Software - ECG analysis software (D300)

Device Class : 2

Duns Number: 827419834

Premarket Exempt : Yes

Product Code : DSH, DQK

Prescription Use : Yes

Device Count : 1

Cardea SOLO - 10857553006112 Catalog Number : M300-5

Device Description : Cardea SOLO Wearable Sensor (M300)

Device Class :

Duns Number: 827419834

Premarket Exempt : No

Product Code : DQK, DSH

Prescription Use : Yes

Device Count : 5

Cardea SOLO - 10857553006129 Catalog Number : C300/D300

Device Description : Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer ca Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer cable (C300).

Device Class : 2

Duns Number: 827419834

Premarket Exempt : No

Product Code : DQK, DSH

Prescription Use : Yes

Device Count : 1

Stealth System S300 - 20857553006072 Catalog Number : M300-5

Device Description : Stealth System Wearable Sensor (M300).

Device Class :

Duns Number: 827419834

Premarket Exempt : No

Product Code : DQK, DSH

Prescription Use : Yes

Device Count : 5

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