K160540 is an FDA 510(k) clearance for the FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM. This device is classified as a Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer (Class II - Special Controls, product code BZE).
Submitted by Flexicare Medical Limited. (Mountain Ash, GB). The FDA issued a Cleared decision on June 23, 2016, 118 days after receiving the submission on February 26, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5270.
| 510(k) Number | K160540 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2016 |
| Decision Date | June 23, 2016 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZE - Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5270 |