K173280 is an FDA 510(k) clearance for the Neonatal ConchaSmart Breathing Circuits. 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 Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on August 2, 2018, 290 days after receiving the submission on October 16, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5270.
| 510(k) Number | K173280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2017 |
| Decision Date | August 02, 2018 |
| Days to Decision | 290 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 |