The following data is part of a premarket notification filed by Besmed Health Business Corp. with the FDA for Besmed Peep Valve.
| Device ID | K160112 |
| 510k Number | K160112 |
| Device Name: | Besmed PEEP Valve |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | BESMED HEALTH BUSINESS CORP. NO.5, LANE 116, WU-KONG 2ND RD New Taipei City, TW |
| Contact | Eric Li |
| Correspondent | Paul Dryden BESMED HEALTH BUSINESS CORP. NO.5, LANE 116, WU-KONG 2ND RD New Taipei City, TW |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-19 |
| Decision Date | 2016-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04716770217307 | K160112 | 000 |
| 04716770205007 | K160112 | 000 |
| 04716770204109 | K160112 | 000 |
| 04716770204000 | K160112 | 000 |
| 04716770203102 | K160112 | 000 |
| 04716770203003 | K160112 | 000 |
| 04716770202105 | K160112 | 000 |
| 04716770202006 | K160112 | 000 |
| 04716770201108 | K160112 | 000 |
| 04716770205106 | K160112 | 000 |
| 04716770206004 | K160112 | 000 |
| 04716770206103 | K160112 | 000 |
| 04716770213453 | K160112 | 000 |
| 04716770213408 | K160112 | 000 |
| 04716770213354 | K160112 | 000 |
| 04716770213309 | K160112 | 000 |
| 04716770213200 | K160112 | 000 |
| 04716770213101 | K160112 | 000 |
| 04716770207100 | K160112 | 000 |
| 04716770207001 | K160112 | 000 |
| 04716770201009 | K160112 | 000 |