MSAS-VANTAGE— 510(k) K053004
Substantially EquivalentBiomeridian, Int.
FDA 510(k) clearance K053004 for MSAS-VANTAGE, Substantially Equivalent on 2006-01-13. Applicant: Biomeridian, Int.. Device class: 2.
Clearance details
- Applicant
- Biomeridian, Int.
- Product code
- Code GZO
- Device class
- Class 2
- Regulation
- 21 CFR 882.1540
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Draper, UT, US
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