BIOSOMNIA-V3— 510(k) K042309
Substantially EquivalentOxford Biosignals Limited
FDA 510(k) clearance K042309 for BIOSOMNIA-V3, Substantially Equivalent on 2004-09-08. 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
- Troy, IL, US
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