Submission Details
| 510(k) Number | K173280 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Neonatal ConchaSmart Breathing Circuits
Aug 2018
Decision
290d
Days
Class 2
Risk
About This 510(k) Submission
K173280 is an FDA 510(k) clearance for the Neonatal ConchaSmart Breathing Circuits, 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 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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