Watermark Medical, Inc.

Address:1117 Perimeter Ctr W Suite W514,Atlanta,GA,30338,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

VENTILATORY EFFORT RECORDER (MNR) (7) Conserver, oxygen (NFB) (5) STIMULATOR, NERVE (ETN) (5)

Premarket Exempt

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ARES 620 Unicorder - 00854485007005 Catalog Number : W00517

Device Description : ARES 620 HST Recorder

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

ARES 620 Unicorder System - 00854485007012 Catalog Number : W01219

Device Description : ARES 620 HST Recorder and Disposables

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : ETN, MNR, NFB

Prescription Use : Yes

Device Count : 1

ARES 620 Home Sleep Test Accessories - 10 pack - 00854485007036 Catalog Number : W03621

Device Description : ARES 620 HST Disposables (non-CoC) x10

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : NFB, ETN

Prescription Use : Yes

Device Count : 1

ARES620 Secure Sleep Test Accessories - 10 pack - 00854485007043 Catalog Number : W04322

Device Description : ARES 620 CoC Disposables - (all disposables plus CoC shield) x10

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : NFB, ETN

Prescription Use : Yes

Device Count : 1

ARES620 Respiration Module Assembly - 00854485007050 Catalog Number : W05023

Device Description : ARES 620 Bluetooth Module

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

ARES620 Respiration Adapter Assembly - 00854485007067 Catalog Number : W06724

Device Description : ARES 620 Effort Belt Adapter

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

ARES620 Respiration Belt Assembly - 00854485007074 Catalog Number : W07425

Device Description : ARES 620 Resp Belt Assembly

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

ARES 610 Unicorder - 00854485007081 Catalog Number : WM1603

Device Description : ARES 610 HST Recorder

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

ARES 610 Unicorder System - 00854485007098 Catalog Number : WMU 1610-001

Device Description : ARES 610 HST Recorder and disposables

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : NFB, MNR, ETN

Prescription Use : Yes

Device Count : 1

ARES 610 Home Sleep Test Accessories - 10 pack - 00854485007104 Catalog Number : WMDK-001

Device Description : ARES 610 HST Disposables x10

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : NFB, ETN

Prescription Use : Yes

Device Count : 1

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