The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for R And D Batteries, Inc. Part Numbers 5310, 5063 & 5211.
| Device ID | K934660 |
| 510k Number | K934660 |
| Device Name: | R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211 |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | R & D BATTERIES, INC. 2224 EAST 117TH ST. P.O. BOX 5007 Burnsville, MN 55337 |
| Contact | Randall C Noddings |
| Correspondent | Randall C Noddings R & D BATTERIES, INC. 2224 EAST 117TH ST. P.O. BOX 5007 Burnsville, MN 55337 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-28 |
| Decision Date | 1993-12-03 |