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FDA 510(k)

TROPIC AIR HEAT-ECHANGER BREATHING AID

K-Number: K821735 · 1982-09-07

ApplicantTropic Air
Decision Date1982-09-07
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TROPIC AIR HEAT-ECHANGER BREATHING AID is the device name listed in this FDA 510(k) record. The listed applicant is Tropic Air. It received FDA 510(k) clearance on 1982-09-07 under 510(k) number K821735. 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 TROPIC AIR HEAT-ECHANGER BREATHING AID?

TROPIC AIR HEAT-ECHANGER BREATHING AID is a medical device that received FDA 510(k) clearance on 1982-09-07. The listed applicant is Tropic Air. The 510(k) number is K821735.

When did TROPIC AIR HEAT-ECHANGER BREATHING AID receive FDA 510(k) clearance?

TROPIC AIR HEAT-ECHANGER BREATHING AID received FDA 510(k) clearance on 1982-09-07, under 510(k) number K821735.

Who is the listed applicant for TROPIC AIR HEAT-ECHANGER BREATHING AID?

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

What is the FDA product code for TROPIC AIR HEAT-ECHANGER BREATHING AID?

The FDA product code for TROPIC AIR HEAT-ECHANGER BREATHING AID is BZE.

Related Clinical Trials

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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

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

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