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FDA 510(k)

DEVILBISS HUMIDIFIER

K-Number: K003626 · 2001-05-04

ApplicantSunrise Medical Hhg, Inc.
Decision Date2001-05-04
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEVILBISS HUMIDIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical Hhg, Inc.. It received FDA 510(k) clearance on 2001-05-04 under 510(k) number K003626. 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 DEVILBISS HUMIDIFIER?

DEVILBISS HUMIDIFIER is a medical device that received FDA 510(k) clearance on 2001-05-04. The listed applicant is Sunrise Medical Hhg, Inc.. The 510(k) number is K003626.

When did DEVILBISS HUMIDIFIER receive FDA 510(k) clearance?

DEVILBISS HUMIDIFIER received FDA 510(k) clearance on 2001-05-04, under 510(k) number K003626.

Who is the listed applicant for DEVILBISS HUMIDIFIER?

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

What is the FDA product code for DEVILBISS HUMIDIFIER?

The FDA product code for DEVILBISS HUMIDIFIER is BTT.

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Other records listing Sunrise Medical Hhg, 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.

K083249QUICKIE RHYTHMK012437DEVILBISS SLEEP RECORDER MODEL # RM60K020329DEVILBISS PD1000K020900DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEMK011229DEVILBISS 9000 SERIES CPAP, MODEL 9001K993492DEVILBISS NEBULIZER MODEL 800

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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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