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 |