K-number	K912620
Device name	OPOMAT MANUAL RESUSCITATOR VENTILATOR
Applicant	Euro-Am Pharma, Inc.
Product code	BTM
Device class	Class II
Decision date	Dec 4, 1991
Decision	Substantially Equivalent
Regulation	868.5915

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View the full FDA submission: accessdata.fda.gov

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OPOMAT MANUAL RESUSCITATOR VENTILATOR

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