K133873 is an FDA 510(k) clearance for the TRIBALL INCENTIVE SPIROMETER. This device is classified as a Spirometer, Therapeutic (incentive) (Class II - Special Controls, product code BWF).
Submitted by Besmed Health Business Corp (New Taipei City, Wu-Ku District, TW). The FDA issued a Cleared decision on April 4, 2014, 105 days after receiving the submission on December 20, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5690.
| 510(k) Number | K133873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2013 |
| Decision Date | April 04, 2014 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BWF - Spirometer, Therapeutic (incentive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5690 |