The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for R&d Batteris, Inc. Part Number 5024, 5027, 5033 And 5035.
Device ID | K951281 |
510k Number | K951281 |
Device Name: | R&D BATTERIS, INC. PART NUMBER 5024, 5027, 5033 AND 5035 |
Classification | Thermometer, Electronic, Clinical |
Applicant | R & D BATTERIES, INC. 400 GATEWAY BLVD. Burnsville, MN 55337 |
Contact | Randall C Noddings |
Correspondent | Randall C Noddings R & D BATTERIES, INC. 400 GATEWAY BLVD. 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 | 1995-03-21 |
Decision Date | 1995-08-18 |