Medi-Aid Basal Thermometer
FDA 510(k) K952756 · Polymedica Industries, Inc.
510(k) numberK952756
Submission
- Device name
- Medi-Aid Basal Thermometer
- Applicant
- Polymedica Industries, Inc.
Golden,, CO, US - Received
- June 16, 1995
- Decision date
- September 25, 1995
- 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
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| K050094 | Lady Comp USALHD · Traditional | Lady Comp USA | 04/20/2006SE |
| 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 |
| 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 |
More from Nishitomo Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| K964701 | Mitraflex Pigmented Wound DressingFRO · Traditional | 02/07/1997SE |
| K963623 | Spyroflex Pigmented Wound DressingMGP · Traditional | 10/25/1996SE |
| K962991 | Basis Baby-Temp Pacifier Digital TherometerFLL · Traditional | 09/12/1996SE |
| K955383 | Spyrocolloid Wound DressingMGP · Traditional | 12/13/1995SN |
| K953885 | Spyroflex Skin ProtectorMGP · Traditional | 11/29/1995SE |
| K952159 | Basis Digital ThermometerFLL · Traditional | 09/22/1995SE |
| K953618 | Spyroflex Wound DressingMGP · Traditional | 08/21/1995SN |
| K951862 | A Gel Wound DressingMGQ · Traditional | 07/12/1995SE |
Questions and answers
When was Medi-Aid Basal Thermometer cleared by the FDA?
Medi-Aid Basal Thermometer (K952756) received a 510(k) decision of Substantially Equivalent on September 25, 1995, 101 days after the submission was received.
What is the product code of K952756?
The FDA product code is LHD – Device, Fertility Diagnostic, Proceptive, a Unclassified device.