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FDA 510(k)

AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006

K-Number: K991484 · 1999-05-13

ApplicantAllegiance Healthcare Corp.
Decision Date1999-05-13
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 is the device name listed in this FDA 510(k) record. The listed applicant is Allegiance Healthcare Corp.. It received FDA 510(k) clearance on 1999-05-13 under 510(k) number K991484. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006?

AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 is a medical device that received FDA 510(k) clearance on 1999-05-13. The listed applicant is Allegiance Healthcare Corp.. The 510(k) number is K991484.

When did AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 receive FDA 510(k) clearance?

AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 received FDA 510(k) clearance on 1999-05-13, under 510(k) number K991484.

Who is the listed applicant for AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006?

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

What is the FDA product code for AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006?

The FDA product code for AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 is BTT.

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Other records listing Allegiance Healthcare Corp. 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.

K023673AIRLIFE DEMAND NASAL CANNULAK023419TRILAMINATE DRAPES/TIBURONK024120MODIFICATION TO TEMNO BIOPSY NEEDLESK024292MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIMK024102DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMK023425DRAPES WITH ABSORBENT REINFORCEMENT

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Related Devices (Code: BTT)

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.

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare LimitedK254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LP

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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