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 ID: K133957
• 510k Number: K133957
• Device Name: DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
• Classification: Attachment, Breathing, Positive End Expiratory Pressure
• Applicant: GALEMED CORP. AMOY EXPORT PROCESSING ZONE, 39 SECTION 3, HAIJING EAST RD Xiamen, Fujian, CN 361000
• Contact: Paul Dryden
• Correspondent: Paul Dryden; GALEMED CORP. AMOY EXPORT PROCESSING ZONE, 39 SECTION 3, HAIJING EAST RD Xiamen, Fujian, CN 361000
• Product Code: BYE
• CFR Regulation Number: 868.5965 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-23
• Decision Date: 2014-04-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
44710810082915	K133957	000