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FDA 510(k)

HUMIDIFIER, WITH OR WITHOUT ADAPTER

K-Number: K830896 · 1983-04-18

ApplicantAirlife, Inc.
Decision Date1983-04-18
Product CodeKFZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HUMIDIFIER, WITH OR WITHOUT ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1983-04-18 under 510(k) number K830896. The device is classified under product code KFZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMIDIFIER, WITH OR WITHOUT ADAPTER?

HUMIDIFIER, WITH OR WITHOUT ADAPTER is a medical device that received FDA 510(k) clearance on 1983-04-18. The listed applicant is Airlife, Inc.. The 510(k) number is K830896.

When did HUMIDIFIER, WITH OR WITHOUT ADAPTER receive FDA 510(k) clearance?

HUMIDIFIER, WITH OR WITHOUT ADAPTER received FDA 510(k) clearance on 1983-04-18, under 510(k) number K830896.

Who is the listed applicant for HUMIDIFIER, WITH OR WITHOUT ADAPTER?

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

What is the FDA product code for HUMIDIFIER, WITH OR WITHOUT ADAPTER?

The FDA product code for HUMIDIFIER, WITH OR WITHOUT ADAPTER is KFZ.

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Other records listing Airlife, Inc. 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.

K834573AQUA TRAPK834570VOLUME VENTILATOR CIRCUIT W/WATER TRAPK834077SINGLE USE NEBULIZER-ADJUST-AIR ENTRAINK833196VOLUME VENTILATOR CIRCUIT-NEBULIZERK833197TRACH SWIVE/CONNECTORK832725DUAL DIAL VENTURI STYLE MASK

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Related Devices (Code: KFZ)

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.

K950116THERASTEAM PERSONAL STEAM INHALERKaz, Inc.K915603VIROTHERM HUMIDIFIERVirotherm LaboratoryK894734RHINOTHERM ULTRA 2Twinmed Products, Inc.K871661WH150 ROOM HUMIDIFIERAssociated Mills, Inc.K871189SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380Sunbeam Appliance Service Co.K862919TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIERTranspirator Technologics, Inc.

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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