MODEL 9216 RESPIRATION/HEART RATE MONITOR

Monitor, Breathing Frequency

AEQUITRON MEDICAL, INC.

The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Model 9216 Respiration/heart Rate Monitor.

Pre-market Notification Details

Device IDK881266
510k NumberK881266
Device Name:MODEL 9216 RESPIRATION/HEART RATE MONITOR
ClassificationMonitor, Breathing Frequency
Applicant AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis,  MN  55447 -4834
ContactKenneth B Herland
CorrespondentKenneth B Herland
AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis,  MN  55447 -4834
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-24
Decision Date1988-06-10

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