BIOSOMNIA— 510(k) K021485
Substantially EquivalentOxford Biosignals Limited
FDA 510(k) clearance K021485 for BIOSOMNIA, Substantially Equivalent on 2002-09-11. Applicant: Oxford Biosignals Limited. Device class: 2.
Clearance details
- Applicant
- Oxford Biosignals Limited
- Product code
- Code OMC
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crofton, MD, US
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