The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for R & D Batteries, Inc. Part # 5003, 5198, 5253.
Device ID | K933642 |
510k Number | K933642 |
Device Name: | R & D BATTERIES, INC. PART # 5003, 5198, 5253 |
Classification | Thermometer, Electronic, Clinical |
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 | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-27 |
Decision Date | 1994-01-10 |