| Device Classification Name |
device, fertility diagnostic, proceptive
|
| 510(k) Number | K981207 |
| Device Name | CLEARPLAN EASY FERTILITY MONITOR |
| Applicant |
| UNIPATH LTD. |
priory business park |
bedford,
|
|
| Contact | louise roberts |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 04/02/1998 |
| Decision Date | 10/28/1998 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
Obstetrics/Gynecology
|
| Review Advisory Committee |
Clinical Chemistry
|
| Statement/Summary/Purged Status |
Statement/purged 510(k)
|
| statement |
statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Expedited Review |
No
|
|
|