EEVA SYSTEM
FDA 510(k) clearance K142147 · decided 2014-11-24
Clearance details
- K-number
- K142147
- Device name
- EEVA SYSTEM
- Applicant
- Auxogyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-05
- Decision date
- 2014-11-24
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- PBH
- Device class
- 2
- Regulation number
- 884.6195
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Menlo Park, CA, 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 |
|---|---|---|
| Embryo Predict (K250781) | Alife Health | 2026-05-15 |
| CHLOE BLAST (K243851) | Fairtility , Ltd. | 2025-08-15 |
| KIDScore D3 (K182798) | Vitrolife A/S | 2019-07-19 |
| EEVA 2.0 (DEN120015) | Auxogyn, Inc. | 2014-06-06 |
Recalls involving this device
No recalls on record reference this clearance.