Identity
- Trade Name
- Sleep Profiler PSG2 FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Sleep Profiler PM3 Device Kit FDA UDI
- Model / Reference
- SP29-1002, SP29-1007 FDA UDI
- Description
- Sleep Profiler PM3 Device Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851113007277 FDA UDI
- 510(k) Number
- K152040 FDA UDI
- FDA Product Code
- OLV FDA UDIOMC FDA UDI
- GMDN Term
- Electroencephalograph 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
Yes
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
Yes
FDA UDI
Category: ElectroencephalographHome-use sleep apnoea recording system
Sleep Profiler PSG2 by Advanced Brain Monitoring, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K152040 also covers:
- Sleep Profiler — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Advanced Brain Monitoring, Inc.
Sources (2)
- FDA UDI 719574b7-2b3f-4aaf-a83e-1e6de5918cce 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 3, 2026