PROTEUS DIGITAL HEALTH, INC.

PROTEUS DIGITAL 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

Ingestible event marker (OZW) (10) TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE (DXH) (10)

Premarket Exempt

No

Clear

NA - 00856602005017 Catalog Number :

Device Class : 2

Duns Number: 149825791

Premarket Exempt : No

Product Code : DXH, OZW

Prescription Use : Yes

Device Count : 1

Proteus Digital Health Feedback System - 00856602005130 Catalog Number :

Device Class :

Duns Number: 149825791

Premarket Exempt : No

Product Code : OZW, DXH

Prescription Use : Yes

Device Count : 1

NA - 00856602005154 Catalog Number :

Device Class : 2

Duns Number: 149825791

Premarket Exempt : No

Product Code : OZW, DXH

Prescription Use : Yes

Device Count : 1

Proteus Digital Health Feedback System - 00856602005215 Catalog Number :

Device Class : 2

Duns Number: 149825791

Premarket Exempt : No

Product Code : OZW, DXH

Prescription Use : Yes

Device Count : 1

Proteus Digital Health Feedback System - 00856602005222 Catalog Number :

Device Class : 2

Duns Number: 149825791

Premarket Exempt : No

Product Code : OZW, DXH

Prescription Use : Yes

Device Count : 1

NA - 10856602005021 Catalog Number :

Device Class :

Duns Number: 149825791

Premarket Exempt : No

Product Code : DXH, OZW

Prescription Use : Yes

Device Count : 2

NA - 10856602005045 Catalog Number :

Device Class :

Duns Number: 149825791

Premarket Exempt : No

Product Code : DXH, OZW

Prescription Use : Yes

Device Count : 100

NA - 10856602005052 Catalog Number :

Device Class :

Duns Number: 149825791

Premarket Exempt : No

Product Code : OZW, DXH

Prescription Use : Yes

Device Count : 250

NA - 10856602005069 Catalog Number :

Device Class :

Duns Number: 149825791

Premarket Exempt : No

Product Code : OZW, DXH

Prescription Use : Yes

Device Count : 450

NA - 10856602005076 Catalog Number :

Device Class :

Duns Number: 149825791

Premarket Exempt : No

Product Code : OZW, DXH

Prescription Use : Yes

Device Count : 30

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