Identity
- Trade Name
- ARES 620 Unicorder System FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- ARES 620 HST Recorder and Disposables FDA UDI
- Model / Reference
- 620 FDA UDI
- Description
- ARES 620 HST Recorder and Disposables FDA UDI
Identifiers
- Catalog Number
- W01219 FDA UDI
- Primary DI / UDI-DI
- 00854485007012 FDA UDI
- 510(k) Number
- K160499 FDA UDI
- FDA Product Code
- ETN FDA UDIMNR FDA UDINFB FDA UDI
- GMDN Term
- Analytical non-scalp cutaneous electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1820 FDA UDI868.2375 FDA UDI868.5905 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nasal oxygen cannula, basicAnalytical non-scalp cutaneous electrodeHome-use sleep apnoea recording systemSkin-cleaning wipe, sterile
ARES 620 Unicorder System by WATERMARK MEDICAL Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160499 also covers:
- ARES 620 Home Sleep Test Accessories - 10 pack — WATERMARK MEDICAL Inc
- ARES 620 Respiration Effort Disposables Kit - 10 pack — WATERMARK MEDICAL Inc
- ARES 620 Respiration Effort System — WATERMARK MEDICAL Inc
- ARES 620 Unicorder — WATERMARK MEDICAL Inc
- ARES620 Respiration Adapter Assembly — WATERMARK MEDICAL Inc
- ARES620 Respiration Adapter Cable — WATERMARK MEDICAL Inc
- ARES620 Respiration Belt Assembly — WATERMARK MEDICAL Inc
- ARES620 Respiration Module Assembly — WATERMARK MEDICAL Inc
- ARES620 Secure Sleep Test Accessories - 10 pack — WATERMARK MEDICAL Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- WATERMARK MEDICAL Inc
Sources (1)
- FDA UDI 994c394b-44fd-45a0-ac99-6851e3a75d01 37 fields · synced May 30, 2026