LHD — Device, Fertility Diagnostic, Proceptive Class U
FDA Device Classification
Classification Details
- Product Code
- LHD
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Unknown
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K200163 | ava | Ava Fertility Tracker | January 19, 2021 |
| K122337 | fertility focus | OVUSENSE | August 6, 2013 |
| K102499 | cambridge temperature concepts | DUOFERTILITY | December 20, 2011 |
| K050094 | lady comp usa | LADY COMP USA | April 20, 2006 |
| K030961 | microlife | MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 | September 12, 2003 |
| K021978 | nishitomo co | PETIT SOPHIA | April 8, 2003 |
| K002726 | ovusoft | TCOYF FERTILITY SOFTWARE VERSION 1.0 | April 6, 2001 |
| K952756 | polymedica industries | MEDI-AID BASAL THERMOMETER | September 25, 1995 |
| K945427 | bd becton dickinson vacutainer systems preanalytic | B-D DIGITAL THERMOMETER | June 15, 1995 |
| K904211 | bioself | BIOSELF 2000 FERTILITY INDICATOR | October 14, 1992 |
| K901512 | nishitomo co | L SOPHIA | July 20, 1990 |
| K880618 | fertile time | FERTILITY FORECASTER COMPUTER PROGRAM | June 24, 1988 |
| K870999 | procare c/o wiley, rein and fielding | GENDER CHOICE INFORMATION KIT, FEMALE AND MALE | July 14, 1987 |
| K870528 | ob/gyn concepts | OVU-TRAC OVULATION TIMING KIT | May 6, 1987 |
| K852194 | sharp electronics | MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET | September 27, 1985 |
| K852801 | fertil-a-chron | BIOCHRON FERTILITY INDICATOR | September 19, 1985 |
| K845009 | sanimor | RABBIT-PERSONAL COMPUTER FOR WOMEN | April 10, 1985 |
| K844043 | joel r.l. ehren kranz | OVUDATE | February 15, 1985 |
| K843699 | bioself | BIOSELF TM 110 | December 4, 1984 |
| K823463 | p.k. morgan instruments | RIGHT TIME RHYTHM CLOCK | March 17, 1983 |