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FDA 510(k)

RESPIRATORY GAS HUMIDIFIER

K-Number: K842597 · 1985-01-16

ApplicantApplinc
Decision Date1985-01-16
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY GAS HUMIDIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Applinc. It received FDA 510(k) clearance on 1985-01-16 under 510(k) number K842597. 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 RESPIRATORY GAS HUMIDIFIER?

RESPIRATORY GAS HUMIDIFIER is a medical device that received FDA 510(k) clearance on 1985-01-16. The listed applicant is Applinc. The 510(k) number is K842597.

When did RESPIRATORY GAS HUMIDIFIER receive FDA 510(k) clearance?

RESPIRATORY GAS HUMIDIFIER received FDA 510(k) clearance on 1985-01-16, under 510(k) number K842597.

Who is the listed applicant for RESPIRATORY GAS HUMIDIFIER?

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

What is the FDA product code for RESPIRATORY GAS HUMIDIFIER?

The FDA product code for RESPIRATORY GAS HUMIDIFIER is BZE.

Related Clinical Trials

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.

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Other records listing Applinc as applicant

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.

K851245ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY

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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