GAMMA PHOTON GAMMA COUNTER

Counter (beta, Gamma) For Clinical Use

MEDICAL & SCIENTIFIC DESIGNS, INC.

The following data is part of a premarket notification filed by Medical & Scientific Designs, Inc. with the FDA for Gamma Photon Gamma Counter.

Pre-market Notification Details

Device IDK832210
510k NumberK832210
Device Name:GAMMA PHOTON GAMMA COUNTER
ClassificationCounter (beta, Gamma) For Clinical Use
Applicant MEDICAL & SCIENTIFIC DESIGNS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJJ  
CFR Regulation Number862.2320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-07
Decision Date1983-08-24

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