The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for B-d Digital Thermometer.
| Device ID | K945427 |
| 510k Number | K945427 |
| Device Name: | B-D DIGITAL THERMOMETER |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Peter Zurlo |
| Correspondent | Peter Zurlo BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | LHD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-04 |
| Decision Date | 1995-06-15 |