Identity
- Trade Name
- EnsoSleep FDA UDI
- Generic Name
- Sleep disorder interpretive software, professional-only FDA UDI
- Device Name
- Automated sleep study scoring and report generation by EnsoData FDA UDI
- Model / Reference
- 8.0 FDA UDI
- Description
- Automated sleep study scoring and report generation by EnsoData FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864458000476 FDA UDI
- 510(k) Number
- K210034 FDA UDI
- FDA Product Code
- OLZ FDA UDI
- GMDN Term
- Sleep disorder interpretive software, professional-only FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 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
Category: Sleep disorder interpretive software, professional-only
EnsoSleep by Ensodata, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K210034 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 66acc31b-b78d-4699-a7a9-0d132f175c9c 34 fields · synced Jun 6, 2026