B-D Digital Thermometer
FDA 510(k) K945427 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK945427
Submission
- Device name
- B-D Digital Thermometer
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lake, NJ, US - Received
- November 4, 1994
- Decision date
- June 15, 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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| 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 |
| K904211 | Bioself 2000 Fertility IndicatorLHD · Traditional | Bioself, Inc. | 10/14/1992SE |
| K901512 | L SophiaLHD · Traditional | Nishitomo Co., Inc. | 07/20/1990SE |
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| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
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Questions and answers
When was B-D Digital Thermometer cleared by the FDA?
B-D Digital Thermometer (K945427) received a 510(k) decision of Substantially Equivalent on June 15, 1995, 223 days after the submission was received.
What is the product code of K945427?
The FDA product code is LHD – Device, Fertility Diagnostic, Proceptive, a Unclassified device.