K161314 is an FDA 510(k) clearance for the FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE. This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by Flexicare Medical Limited. (Mountain Ash, GB). The FDA issued a Cleared decision on July 6, 2016, 56 days after receiving the submission on May 11, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K161314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2016 |
| Decision Date | July 06, 2016 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5450 |