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FDA 510(k)

DEVILBISS 9000 SERIES CPAP, MODEL 9001

K-Number: K011229 · 2001-07-11

ApplicantSunrise Medical Hhg, Inc.
Decision Date2001-07-11
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEVILBISS 9000 SERIES CPAP, MODEL 9001 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 2001-07-11 under 510(k) number K011229. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEVILBISS 9000 SERIES CPAP, MODEL 9001?

DEVILBISS 9000 SERIES CPAP, MODEL 9001 is a medical device that received FDA 510(k) clearance on 2001-07-11. The listed applicant is Sunrise Medical Hhg, Inc.. The 510(k) number is K011229.

When did DEVILBISS 9000 SERIES CPAP, MODEL 9001 receive FDA 510(k) clearance?

DEVILBISS 9000 SERIES CPAP, MODEL 9001 received FDA 510(k) clearance on 2001-07-11, under 510(k) number K011229.

Who is the listed applicant for DEVILBISS 9000 SERIES CPAP, MODEL 9001?

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 9000 SERIES CPAP, MODEL 9001?

The FDA product code for DEVILBISS 9000 SERIES CPAP, MODEL 9001 is BZD.

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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 SYSTEMK003626DEVILBISS HUMIDIFIERK993492DEVILBISS NEBULIZER MODEL 800

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Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

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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