R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502

Ophthalmoscope, Battery-powered

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. 5135, 5097, 5444, And 5502.

Pre-market Notification Details

Device IDK942034
510k NumberK942034
Device Name:R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502
ClassificationOphthalmoscope, Battery-powered
Applicant R & D BATTERIES, INC. 2224 EAST 117TH ST. P.O. BOX 5007 Burnsville,  MN  55337
ContactRandall C Noddings
CorrespondentRandall C Noddings
R & D BATTERIES, INC. 2224 EAST 117TH ST. P.O. BOX 5007 Burnsville,  MN  55337
Product CodeHLJ  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-28
Decision Date1994-06-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810149094644 K942034 000
00810149090684 K942034 000
00810149090745 K942034 000
00810149090837 K942034 000
00810149091056 K942034 000
00810149091148 K942034 000
00810149092039 K942034 000
00810149093630 K942034 000
00810149093647 K942034 000
00810149094637 K942034 000
00810149097515 K942034 000

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