FERTILITE OV
FDA 510(k) clearance K020808 · decided 2002-09-23
Clearance details
- K-number
- K020808
- Device name
- FERTILITE OV
- Applicant
- Pheromone Sciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-12
- Decision date
- 2002-09-23
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- NGE
- Device class
- 1
- Regulation number
- 862.1485
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Toronto, CA
- 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 |
|---|---|---|
| MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR (K990223) | Unipath , Ltd. | 1999-02-24 |
| CLEARPLAN EASY FERTILITY MONITOR (K981207) | Unipath , Ltd. | 1998-10-28 |
| OVULON MONITOR (K973860) | Conception Technology, Inc. | 1998-01-07 |
| PEAK OVULATION PREDICTOR (K863121) | Micron Technology, Inc. | 1986-10-14 |
| CUE FERTILITY MONITOR (K850579) | Zetek, Inc. | 1985-03-22 |
Recalls involving this device
No recalls on record reference this clearance.