Identity
- Trade Name
- Celeste+ FDA UDI
- Generic Name
- Sleep disorder interpretive software, professional-only FDA UDI
- Device Name
- Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices FDA UDI
- Model / Reference
- 8.0 FDA UDI
- Description
- Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864458000452 FDA UDI
- 510(k) Number
- K173974 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Sleep disorder interpretive software, professional-only 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
No
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
Category: Sleep disorder interpretive software, professional-only
Celeste+ by Ensodata, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K173974 also covers:
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
- Ensodata, Inc.
Sources (1)
- FDA UDI adbd92f4-4c05-4213-a28b-ee673217a12c 34 fields · synced Jun 6, 2026