R&D BATTERIES PART NOS. 5064, 5157, 5489 AND 5536

Thermometer, Electronic, Clinical

R & D BATTERIES, INC.

The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for R&d Batteries Part Nos. 5064, 5157, 5489 And 5536.

Pre-market Notification Details

Device IDK951400
510k NumberK951400
Device Name:R&D BATTERIES PART NOS. 5064, 5157, 5489 AND 5536
ClassificationThermometer, Electronic, Clinical
Applicant R & D BATTERIES, INC. 400 GATEWAY BLVD. Burnsville,  MN  55337
ContactRandall C Noddings
CorrespondentRandall C Noddings
R & D BATTERIES, INC. 400 GATEWAY BLVD. Burnsville,  MN  55337
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-28
Decision Date1995-08-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.