Identity
- Trade Name
- ARES620 Respiration Module Assembly FDA UDI
- Generic Name
- Home-use sleep apnoea recording system FDA UDI
- Device Name
- ARES 620 Bluetooth Module FDA UDI
- Model / Reference
- 620 FDA UDI
- Description
- ARES 620 Bluetooth Module FDA UDI
Identifiers
- Catalog Number
- W05023 FDA UDI
- Primary DI / UDI-DI
- 00854485007050 FDA UDI
- 510(k) Number
- K160499 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Home-use sleep apnoea recording system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Home-use sleep apnoea recording system
ARES620 Respiration Module Assembly by WATERMARK MEDICAL Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home-use sleep apnoea recording system.
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- Cadwell — Cadwell Industries, Inc. · Class II
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- NomadAir PMU810 Portable Recorder — Neurotronics, LLC · Class II
- Cadwell — Cadwell Industries, Inc. · Class II
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
- ARES 620 Unicorder System — 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 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 439e1d2a-53da-44f9-b39c-c4dba3026d64 36 fields · synced May 30, 2026