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 |