The following data is part of a premarket notification filed by Galemed Corp. with the FDA for Disposable Adjustable Peep Valve Mr Conditional Use.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
44710810082915 | K133957 | 000 |
50885403175990 | K133957 | 000 |
50885403175983 | K133957 | 000 |
46923980114340 | K133957 | 000 |