CAP-RIA 16

Counter (beta, Gamma) For Clinical Use

CAPINTEC, INC.

The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Cap-ria 16.

Pre-market Notification Details

Device IDK823240
510k NumberK823240
Device Name:CAP-RIA 16
ClassificationCounter (beta, Gamma) For Clinical Use
Applicant CAPINTEC, 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 Received1982-11-01
Decision Date1982-12-03

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