CAPTUS 500

Probe, Uptake, Nuclear

CAPINTEC INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Capintec Instruments, Inc. with the FDA for Captus 500.

Pre-market Notification Details

Device IDK921428
510k NumberK921428
Device Name:CAPTUS 500
ClassificationProbe, Uptake, Nuclear
Applicant CAPINTEC INSTRUMENTS, INC. 540 ALPHA DR. Pittsburgh,  PA  15238
ContactAnn Dell
CorrespondentAnn Dell
CAPINTEC INSTRUMENTS, INC. 540 ALPHA DR. Pittsburgh,  PA  15238
Product CodeIZD  
CFR Regulation Number892.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-24
Decision Date1992-05-28

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