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FDA 510(k)

Neonatal ConchaSmart Breathing Circuits

K-Number: K173280 · 2018-08-02

ApplicantTeleflexmedical, Inc.
Decision Date2018-08-02
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Neonatal ConchaSmart Breathing Circuits is a medical device manufactured by Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2018-08-02 under approval number K173280. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neonatal ConchaSmart Breathing Circuits?

Neonatal ConchaSmart Breathing Circuits is a medical device that received FDA 510(k) clearance on 2018-08-02. It is manufactured by Teleflexmedical, Inc.. The 510(k) number is K173280.

When was Neonatal ConchaSmart Breathing Circuits approved by the FDA?

Neonatal ConchaSmart Breathing Circuits received FDA 510(k) clearance on 2018-08-02, under approval number K173280.

What company makes Neonatal ConchaSmart Breathing Circuits?

Neonatal ConchaSmart Breathing Circuits is manufactured by Teleflexmedical, Inc..

What is the FDA product code for Neonatal ConchaSmart Breathing Circuits?

The FDA product code for Neonatal ConchaSmart Breathing Circuits is BZE.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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