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FDA 510(k)

BILEVEL CPAP, MODEL 9055 SERIES

K-Number: K032056 · 2004-02-20

ApplicantSunrise Medical
Decision Date2004-02-20
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BILEVEL CPAP, MODEL 9055 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical. It received FDA 510(k) clearance on 2004-02-20 under 510(k) number K032056. 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 BILEVEL CPAP, MODEL 9055 SERIES?

BILEVEL CPAP, MODEL 9055 SERIES is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Sunrise Medical. The 510(k) number is K032056.

When did BILEVEL CPAP, MODEL 9055 SERIES receive FDA 510(k) clearance?

BILEVEL CPAP, MODEL 9055 SERIES received FDA 510(k) clearance on 2004-02-20, under 510(k) number K032056.

Who is the listed applicant for BILEVEL CPAP, MODEL 9055 SERIES?

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

What is the FDA product code for BILEVEL CPAP, MODEL 9055 SERIES?

The FDA product code for BILEVEL CPAP, MODEL 9055 SERIES is BZD.

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Other records listing Sunrise Medical as applicant

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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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