DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE

Attachment, Breathing, Positive End Expiratory Pressure

GALEMED CORP.

The following data is part of a premarket notification filed by Galemed Corp. with the FDA for Disposable Adjustable Peep Valve Mr Conditional Use.

Pre-market Notification Details

Device IDK133957
510k NumberK133957
Device Name:DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
ClassificationAttachment, Breathing, Positive End Expiratory Pressure
Applicant GALEMED CORP. AMOY EXPORT PROCESSING ZONE, 39 SECTION 3, HAIJING EAST RD Xiamen, Fujian,  CN 361000
ContactPaul Dryden
CorrespondentPaul Dryden
GALEMED CORP. AMOY EXPORT PROCESSING ZONE, 39 SECTION 3, HAIJING EAST RD Xiamen, Fujian,  CN 361000
Product CodeBYE  
CFR Regulation Number868.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-23
Decision Date2014-04-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
44710810082915 K133957 000
50885403175990 K133957 000
50885403175983 K133957 000
46923980114340 K133957 000

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