The following data is part of a premarket notification filed by Becton Dickinson Consumer Products with the FDA for B-d Assure Ear Thermometer.
| Device ID | K971994 |
| 510k Number | K971994 |
| Device Name: | B-D ASSURE EAR THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | BECTON DICKINSON CONSUMER PRODUCTS ONE BECTON DR. Franklin Lake, NJ 07417 -1883 |
| Contact | Peter Zurlo |
| Correspondent | Peter Zurlo BECTON DICKINSON CONSUMER PRODUCTS ONE BECTON DR. Franklin Lake, NJ 07417 -1883 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-29 |
| Decision Date | 1998-05-01 |
| Summary: | summary |