The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for R &d Batteries, Inc. Part # 5015, 5192, 5482.
Device ID | K933513 |
510k Number | K933513 |
Device Name: | R &D BATTERIES, INC. PART # 5015, 5192, 5482 |
Classification | Camera, Scintillation (gamma) |
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 | IYX |
CFR Regulation Number | 892.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-20 |
Decision Date | 1993-11-24 |