CRITICALC

Computer, Diagnostic, Programmable

CYGNUS OF SOUTH FLORIDA, INC.

The following data is part of a premarket notification filed by Cygnus Of South Florida, Inc. with the FDA for Criticalc.

Pre-market Notification Details

Device IDK860854
510k NumberK860854
Device Name:CRITICALC
ClassificationComputer, Diagnostic, Programmable
Applicant CYGNUS OF SOUTH FLORIDA, INC. 560 N.W. 165TH RD. SUITE 309 MIAMI,  FL  33169
ContactALAN SEGAL
CorrespondentALAN SEGAL
CYGNUS OF SOUTH FLORIDA, INC. 560 N.W. 165TH RD. SUITE 309 MIAMI,  FL  33169
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-07
Decision Date1986-12-08

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