Identity
- Trade Name
- Xltek FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Oximeter Embletta/Embla7000 XPOD FDA UDI
- Model / Reference
- 1430000 FDA UDI
- Description
- Oximeter Embletta/Embla7000 XPOD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830024655 FDA UDI
- 510(k) Number
- K024322 FDA UDI
- FDA Product Code
- MNR 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polysomnograph
Xltek by Embla Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polysomnograph.
- Snore Sensor — Respironics, Inc. · Class II
- SleepmateSnoring Microphone — Ambu A/S · Class II
- Perfect Fit — Dymedix Diagnostics, Inc. · Class II
- Cadwell — Cadwell Industries, Inc. · Class II
- TriplePlay — Dymedix Diagnostics, Inc. · Class II
- Perfect Fit — Dymedix Diagnostics, Inc. · Class II
- micromed — Micromed, Inc. · Class II
- Cadwell — Cadwell Industries, Inc. · Class II
Cleared under the same submission
K024322 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Embla Systems
Sources (1)
- FDA UDI 6fabbeab-497e-40a7-9180-1c603d3417b6 34 fields · synced May 30, 2026