Identity
- Trade Name
- Embla FDA UDI
- Generic Name
- Polysomnography analyser FDA UDI
- Model / Reference
- 4140099 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290013817327 FDA UDI
- 510(k) Number
- K042253 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Polysomnography analyser 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polysomnography analyser
Embla by S. L. P. Scientific Laboratory Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K042253 also covers:
- Clevemed — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Clevemed — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Embla — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Embla — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Embla — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Grass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Grass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Grass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Grass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Grass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Neurovirtual — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Neurovirtual — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
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
- S. L. P. Scientific Laboratory Products Ltd
Sources (1)
- FDA UDI a3dbebc0-6819-4c38-a519-0766624aab82 33 fields · synced May 30, 2026