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FDA 510(k)

HUMIDIFIER W/ OR W/OUT ADAPTOR

K-Number: K811161 · 1981-06-24

ApplicantAirlife, Inc.
Decision Date1981-06-24
Product CodeKFZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HUMIDIFIER W/ OR W/OUT ADAPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1981-06-24 under 510(k) number K811161. 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 W/ OR W/OUT ADAPTOR?

HUMIDIFIER W/ OR W/OUT ADAPTOR is a medical device that received FDA 510(k) clearance on 1981-06-24. The listed applicant is Airlife, Inc.. The 510(k) number is K811161.

When did HUMIDIFIER W/ OR W/OUT ADAPTOR receive FDA 510(k) clearance?

HUMIDIFIER W/ OR W/OUT ADAPTOR received FDA 510(k) clearance on 1981-06-24, under 510(k) number K811161.

Who is the listed applicant for HUMIDIFIER W/ OR W/OUT ADAPTOR?

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 W/ OR W/OUT ADAPTOR?

The FDA product code for HUMIDIFIER W/ OR W/OUT ADAPTOR 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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