AHI System— 510(k) K212219
Substantially EquivalentFifth Eye, Inc.
FDA 510(k) clearance K212219 for AHI System, Substantially Equivalent on 2021-12-03. Applicant: Fifth Eye, Inc.. Device class: 2.
Clearance details
- Applicant
- Fifth Eye, Inc.
- Product code
- Code QNV
- Device class
- Class 2
- Regulation
- 21 CFR 870.2220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Recent devices under product code QNV
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