CLEARPLAN EASY FERTILITY MONITOR
FDA 510(k) clearance K981207 · decided 1998-10-28
Clearance details
- K-number
- K981207
- Device name
- CLEARPLAN EASY FERTILITY MONITOR
- Applicant
- Unipath , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-02
- Decision date
- 1998-10-28
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- NGE
- Device class
- 1
- Regulation number
- 862.1485
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bedford, GB
- 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 |
|---|---|---|
| FERTILITE OV (K020808) | Pheromone Sciences Corp. | 2002-09-23 |
| MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR (K990223) | Unipath , Ltd. | 1999-02-24 |
| 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.