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) (1) Conserver, oxygen (NFB) (1) STIMULATOR, NERVE (ETN) (1)

Premarket Exempt

Clear

ARES 610 Home Sleep Test Accessories - 50 Pack - 00854485007111 Catalog Number : WM 1006

Device Description : ARES 610 HST Disposables x50

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : NFB, ETN

Prescription Use : Yes

Device Count : 1

ARES Secure Sleep Study Accessories - 00854485007128 Catalog Number : WM 1003

Device Description : ARES Secure Sleep Study Accessories (Dongle and cable pack)

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

ARES Secure Sleep Study Disposable Kit - 10 pack - 00854485007135 Catalog Number : WM-1004

Device Description : ARES Secure Sleep Study Disposable Kit (neck collars) - x10

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

ARES COC Cable - 00854485007142 Catalog Number : W14205

Device Description : ARES CoC Cable

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

ARES COC Dongle - 00854485007159 Catalog Number : W15906

Device Description : ARES CoC Dongle

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

ARES620 Respiration Adapter Cable - 00854485007166 Catalog Number : W16626

Device Description : ARES 620 Resp Adapter Cable

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

ARES 620 Respiration Effort System - 00854485007173 Catalog Number : W17327

Device Description : ARES 620 Resp Effort System Kit

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

ARES 620 Respiration Effort Disposables Kit - 10 pack - 00854485007180 Catalog Number : W18028

Device Description : ARES 620 Resp Effort Disposables Kit x10

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

ARES Nasal Cannula - 00854485007197 Catalog Number : W19729

Device Description : ARES Nasal Cannula

Device Class : 2

Duns Number: 017159127

Premarket Exempt : No

Product Code : NFB

Prescription Use : Yes

Device Count : 1

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