CAMERON HEALTH, INC.

CAMERON HEALTH, INC.

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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

Implantable cardioverter defibrillator (non-CRT) (LWS) (9)

Premarket Exempt

No

Clear

SQ-RX® PULSE GENERATOR - 00802526521300 Catalog Number :

Device Description : SQ-RX Pulse Generator

Device Class : 3

Duns Number: 017134557

Premarket Exempt : No

Product Code : LWS

Prescription Use : Yes

Device Count : 1

S-ICD® System Patient Screening Tool - 00802526524806 Catalog Number :

Device Description : Patient Screening Tool

Device Class : 3

Duns Number: 017134557

Premarket Exempt : No

Product Code : LWS

Prescription Use : No

Device Count : 1

The Q-GUIDE™ Electrode Insertion Tool - 00802526531019 Catalog Number :

Device Description : Electrode Insertion Tool

Device Class : 3

Duns Number: 017134557

Premarket Exempt : No

Product Code : LWS

Prescription Use : Yes

Device Count : 1

S-ICD® System Magnet - 00802526531033 Catalog Number :

Device Description : Magnet

Device Class : 3

Duns Number: 017134557

Premarket Exempt : No

Product Code : LWS

Prescription Use : Yes

Device Count : 1

Q TECH - 00802526542206 Catalog Number :

Device Description : Programmer for the S-ICD® System

Device Class : 3

Duns Number: 017134557

Premarket Exempt : No

Product Code : LWS

Prescription Use : Yes

Device Count : 1

Q-TECH™ - 00802526542244 Catalog Number :

Device Description : Power Supply for S-ICD Programmer 3200

Device Class : 3

Duns Number: 017134557

Premarket Exempt : No

Product Code : LWS

Prescription Use : Yes

Device Count : 1

SQ-RX® PULSE GENERATOR - 00802526562808 Catalog Number :

Device Description : SQ-RX Pulse Generator

Device Class : 3

Duns Number: 017134557

Premarket Exempt : No

Product Code : LWS

Prescription Use : Yes

Device Count : 1

The Q-TRAK™ Subcutaneous Electrode - 00802526563201 Catalog Number :

Device Description : Electrode

Device Class : 3

Duns Number: 017134557

Premarket Exempt : No

Product Code : LWS

Prescription Use : Yes

Device Count : 1

The Q-GUIDE™ Electrode Insertion Tool - 00802526569401 Catalog Number :

Device Description : Electrode Insertion Tool

Device Class : 3

Duns Number: 017134557

Premarket Exempt : No

Product Code : LWS

Prescription Use : Yes

Device Count : 1

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