The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for R&d Batteries, Inc. Part Numbers 5003, 5006, 5008 And 5012.
| Device ID | K951280 |
| 510k Number | K951280 |
| Device Name: | R&D BATTERIES, INC. PART NUMBERS 5003, 5006, 5008 AND 5012 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | R & D BATTERIES, INC. 400 GATEWAY BLVD. Burnsville, MN 55337 |
| Contact | Randall C Noddings |
| Correspondent | Randall C Noddings R & D BATTERIES, INC. 400 GATEWAY BLVD. Burnsville, MN 55337 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-21 |
| Decision Date | 1995-08-18 |