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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 the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2018-08-02 under 510(k) 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. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K173280.

When did Neonatal ConchaSmart Breathing Circuits receive FDA 510(k) clearance?

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

Who is the listed applicant for Neonatal ConchaSmart Breathing Circuits?

The FDA 510(k) record lists Teleflexmedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: BZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)Vincent Healthcare Products LimitedK253322Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)Medline Industries, LPK243244Heated Breathing TubeGuangdong Eda Technology Co., Ltd.K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron MedicalK234032Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension LineMedline Industries, LPK222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO Kgaa

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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