PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS

Circuit, Breathing (w Connector, Adaptor, Y Piece)

PRIMA, INC.

The following data is part of a premarket notification filed by Prima, Inc. with the FDA for Prima Adult Temperature Monitoring Anesthesia Circuits.

Pre-market Notification Details

Device IDK952014
510k NumberK952014
Device Name:PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
ClassificationCircuit, Breathing (w Connector, Adaptor, Y Piece)
Applicant PRIMA, INC. 1300 25TH ST. PLAZA SUITE 11 Cleveland,  TN  37311
ContactRobert Steinbarger
CorrespondentRobert Steinbarger
PRIMA, INC. 1300 25TH ST. PLAZA SUITE 11 Cleveland,  TN  37311
Product CodeCAI  
CFR Regulation Number868.5240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-28
Decision Date1995-05-22

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