K945427 is an FDA 510(k) clearance for the B-D DIGITAL THERMOMETER. This device is classified as a Device, Fertility Diagnostic, Proceptive.
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lake, US). The FDA issued a Cleared decision on June 15, 1995, 223 days after receiving the submission on November 4, 1994.
This device falls under the Obstetrics & Gynecology FDA review panel.
| 510(k) Number | K945427 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 1994 |
| Decision Date | June 15, 1995 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | LHD — Device, Fertility Diagnostic, Proceptive |
| Device Class | — |