K160112 is an FDA 510(k) clearance for the Besmed PEEP Valve. This device is classified as a Attachment, Breathing, Positive End Expiratory Pressure (Class II - Special Controls, product code BYE).
Submitted by Besmed Health Business Corp (New Taipei City, TW). The FDA issued a Cleared decision on April 29, 2016, 101 days after receiving the submission on January 19, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5965.
| 510(k) Number | K160112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2016 |
| Decision Date | April 29, 2016 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BYE - Attachment, Breathing, Positive End Expiratory Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5965 |