OVUSENSE
Device, Fertility Diagnostic, Proceptive
FERTILITY FOCUS LTD
The following data is part of a premarket notification filed by Fertility Focus Ltd with the FDA for Ovusense.
Pre-market Notification Details
| Device ID | K122337 |
| 510k Number | K122337 |
| Device Name: | OVUSENSE |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | FERTILITY FOCUS LTD 717 LAKEGLEN DRIVE Suwanee, GA 30024 |
| Contact | Penny Northcutt |
| Correspondent | Penny Northcutt FERTILITY FOCUS LTD 717 LAKEGLEN DRIVE Suwanee, GA 30024 |
| Product Code | LHD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-02 |
| Decision Date | 2013-08-06 |
| Summary: | summary |
Trademark Results [OVUSENSE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OVUSENSE 85764297 4516986 Live/Registered |
FERTILITY FOCUS LIMITED 2012-10-26 |
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