Identity
- Trade Name
- Cadwell FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Snore Microphone FDA UDI
- Model / Reference
- 302563-200-1024 FDA UDI
- Description
- Snore Microphone FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840067103371 FDA UDI
- 510(k) Number
- K941759 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- GMDN Term
- Polysomnograph 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 60 Centimeter FDA UDI
Category: PolysomnographHome-use sleep apnoea recording system
Cadwell by Cadwell Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K941759 also covers:
- SleepmateSnore Sensor - 60 cm wire — Ambu A/S
- SleepmateSnoring Microphone — Ambu A/S
- SleepmateSnoring Microphone - Alice 3 — Ambu A/S
- SleepmateSnoring Microphone - Alice 4 — Ambu A/S
- SleepmateSnoring Piezo Sensor — Ambu A/S
- Snore Microphone 60cm-CadwellSleepmate — Ambu A/S
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cadwell Industries, Inc.
Sources (1)
- FDA UDI 67093036-6685-4b66-b11e-bbe3fe945ac7 36 fields · synced Jun 9, 2026