AHI System
FDA 510(k) clearance K221203 · decided 2022-07-14
Clearance details
- K-number
- K221203
- Device name
- AHI System
- Applicant
- Fifth Eye, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-26
- Decision date
- 2022-07-14
- Days to decision
- 79 days
- Clearance type
- Special
- Product code
- QNV
- Device class
- 2
- Regulation number
- 870.2220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AHI System (K212219) | Fifth Eye, Inc. | 2021-12-03 |
| Analytic for Hemodynamic Instability (AHI) (DEN200022) | Fifth Eye, Inc. | 2021-03-01 |
Recalls involving this device
No recalls on record reference this clearance.