COMPANION 50 REGULATOR/FLOWMETER

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

PURITAN BENNETT CORP.

The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Companion 50 Regulator/flowmeter.

Pre-market Notification Details

Device IDK872443
510k NumberK872443
Device Name:COMPANION 50 REGULATOR/FLOWMETER
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park,  KS  66225
ContactHartley C Ericson
CorrespondentHartley C Ericson
PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park,  KS  66225
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-23
Decision Date1987-07-21

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