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 5235, 5506 & 5050.
| Device ID | K935301 |
| 510k Number | K935301 |
| Device Name: | R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050 |
| Classification | System, Monitoring, Perinatal |
| Applicant | R & D BATTERIES, INC. P.O. BOX 5007 Burnsville, MN 55337 |
| Contact | Randall C Noddings |
| Correspondent | Randall C Noddings R & D BATTERIES, INC. P.O. BOX 5007 Burnsville, MN 55337 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-03 |
| Decision Date | 1994-12-05 |