Submission Details
| 510(k) Number | K160540 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
Jun 2016
Decision
118d
Days
Class 2
Risk
About This 510(k) Submission
K160540 is an FDA 510(k) clearance for the FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM, 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 review panel. Regulated under 21 CFR 868.5270.
Device Classification
| 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 |
Manufacturer
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