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Background Pattern Classification [BPc(TM)]
FDA 510(k)Class II (US FDA 510(k))
510(k) K152301
Identifiers
- 510(k) Number
- K152301 FDA 510(k)
- FDA Product Code
- OMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1400 FDA 510(k)
- Regulation Number
- 882.1400 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Background Pattern Classification [BPc(TM)] by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152301 | Class II | Active |
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Manufacturer
- FDA Applicant
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Sources (1)
- FDA 510(k) K152301 24 fields · synced Jun 18, 2026