Lady Comp USA
FDA 510(k) K050094 · Lady Comp USA
510(k) numberK050094
Submission
- Device name
- Lady Comp USA
- Applicant
- Lady Comp USA
Jeffersonville, IN, US - Received
- January 14, 2005
- Decision date
- April 20, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LHD – Device, Fertility Diagnostic, Proceptive
- Device class
- Unclassified
Other 510(k)s with product code LHD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200163 | Ava Fertility TrackerLHD · Traditional | Ava AG | 01/19/2021SE |
| K122337 | OvusenseLHD · Traditional | Fertility Focus, Ltd. | 08/06/2013SE |
| K102499 | DuofertilityLHD · Traditional | Cambridge Temperature Concepts , Ltd. | 12/20/2011SE |
| K030961 | Microlife Digital Basal Thermometer, Model MT 1921LHD · Traditional | Microlife Corp. | 09/12/2003SE |
| K021978 | Petit SophiaLHD · Traditional | Nishitomo Co., Inc. | 04/08/2003SE |
| K002726 | Tcoyf Fertility Software Version 1.0LHD · Traditional | Ovusoft, LLC | 04/06/2001SE |
| K952756 | Medi-Aid Basal ThermometerLHD · Traditional | Polymedica Industries, Inc. | 09/25/1995SE |
| K945427 | B-D Digital ThermometerLHD · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/15/1995SE |
| K904211 | Bioself 2000 Fertility IndicatorLHD · Traditional | Bioself, Inc. | 10/14/1992SE |
| K901512 | L SophiaLHD · Traditional | Nishitomo Co., Inc. | 07/20/1990SE |
Questions and answers
When was Lady Comp USA cleared by the FDA?
Lady Comp USA (K050094) received a 510(k) decision of Substantially Equivalent on April 20, 2006, 461 days after the submission was received.
What is the product code of K050094?
The FDA product code is LHD – Device, Fertility Diagnostic, Proceptive, a Unclassified device.