K140370 is an FDA 510(k) clearance for the DISPOSABLE PRESSURE MANOMETER. This device is classified as a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II - Special Controls, product code CAP).
Submitted by Besmed Health Business Corp (New Taipei City, Wu-Ku District, TW). The FDA issued a Cleared decision on June 19, 2014, 125 days after receiving the submission on February 14, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2600.
| 510(k) Number | K140370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2014 |
| Decision Date | June 19, 2014 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAP - Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2600 |