The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for R&d Batteries # 5615, 5234, 5097.
| Device ID | K935988 |
| 510k Number | K935988 |
| Device Name: | R&D BATTERIES # 5615, 5234, 5097 |
| Classification | Ophthalmoscope, Ac-powered |
| 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 | HLI |
| Subsequent Product Code | HLJ |
| Subsequent Product Code | HPQ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-14 |
| Decision Date | 1994-02-22 |