LHD — Device, Fertility Diagnostic, Proceptive Class U
FDA product code LHD covers "Device, Fertility Diagnostic, Proceptive", a Class U medical device. Submissions are reviewed by the Unknown panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 | Jan 19, 2021 |
| K122337 | Fertility Focus | OVUSENSE | Aug 6, 2013 |
| K102499 | Cambridge Temperature Concepts | DUOFERTILITY | Dec 20, 2011 |
| K050094 | Lady Comp Usa | LADY COMP USA | Apr 20, 2006 |
| K030961 | Microlife | MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 | Sep 12, 2003 |
| K021978 | Nishitomo Co | PETIT SOPHIA | Apr 8, 2003 |
| K002726 | Ovusoft | TCOYF FERTILITY SOFTWARE VERSION 1.0 | Apr 6, 2001 |
| K952756 | Polymedica Industries | MEDI-AID BASAL THERMOMETER | Sep 25, 1995 |
| K945427 | Bd Becton Dickinson Vacutainer Systems Preanalytic | B-D DIGITAL THERMOMETER | Jun 15, 1995 |
| K904211 | Bioself | BIOSELF 2000 FERTILITY INDICATOR | Oct 14, 1992 |
| K901512 | Nishitomo Co | L SOPHIA | Jul 20, 1990 |
| K880618 | Fertile Time | FERTILITY FORECASTER COMPUTER PROGRAM | Jun 24, 1988 |
| K870999 | Procare C/O Wiley, Rein And Fielding | GENDER CHOICE INFORMATION KIT, FEMALE AND MALE | Jul 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 | Sep 27, 1985 |
| K852801 | Fertil-A-Chron | BIOCHRON FERTILITY INDICATOR | Sep 19, 1985 |
| K845009 | Sanimor | RABBIT-PERSONAL COMPUTER FOR WOMEN | Apr 10, 1985 |
| K844043 | Joel R.L. Ehren Kranz | OVUDATE | Feb 15, 1985 |
| K843699 | Bioself | BIOSELF TM 110 | Dec 4, 1984 |
| K823463 | P.K. Morgan Instruments | RIGHT TIME RHYTHM CLOCK | Mar 17, 1983 |