OVUSENSE
FDA 510(k) clearance K122337 · decided 2013-08-06
Clearance details
- K-number
- K122337
- Device name
- OVUSENSE
- Applicant
- Fertility Focus, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-08-02
- Decision date
- 2013-08-06
- Days to decision
- 369 days
- Clearance type
- Traditional
- Product code
- LHD
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Swanee, GA, 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 |
|---|---|---|
| Ava Fertility Tracker (K200163) | Ava AG | 2021-01-19 |
| DUOFERTILITY (K102499) | Cambridge Temperature Concepts , Ltd. | 2011-12-20 |
| LADY COMP USA (K050094) | Lady Comp USA | 2006-04-20 |
| MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 (K030961) | Microlife Corp. | 2003-09-12 |
| PETIT SOPHIA (K021978) | Nishitomo Co., Inc. | 2003-04-08 |
| TCOYF FERTILITY SOFTWARE VERSION 1.0 (K002726) | Ovusoft, LLC | 2001-04-06 |
| MEDI-AID BASAL THERMOMETER (K952756) | Polymedica Industries, Inc. | 1995-09-25 |
| B-D DIGITAL THERMOMETER (K945427) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-06-15 |
| BIOSELF 2000 FERTILITY INDICATOR (K904211) | Bioself, Inc. | 1992-10-14 |
| L SOPHIA (K901512) | Nishitomo Co., Inc. | 1990-07-20 |
| FERTILITY FORECASTER COMPUTER PROGRAM (K880618) | Fertile Time, Ltd. | 1988-06-24 |
| GENDER CHOICE INFORMATION KIT, FEMALE AND MALE (K870999) | Procare C/O Wiley, Rein & Fielding | 1987-07-14 |
Recalls involving this device
No recalls on record reference this clearance.