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FDA 510(k)

DEVILBISS AUTOADJUST, MODEL 9054 SERIES

K-Number: K043282 · 2005-02-11

ApplicantSunrise Medical
Decision Date2005-02-11
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEVILBISS AUTOADJUST, MODEL 9054 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 2005-02-11 under 510(k) number K043282. 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 AUTOADJUST, MODEL 9054 SERIES?

DEVILBISS AUTOADJUST, MODEL 9054 SERIES is a medical device that received FDA 510(k) clearance on 2005-02-11. The listed applicant is Sunrise Medical. The 510(k) number is K043282.

When did DEVILBISS AUTOADJUST, MODEL 9054 SERIES receive FDA 510(k) clearance?

DEVILBISS AUTOADJUST, MODEL 9054 SERIES received FDA 510(k) clearance on 2005-02-11, under 510(k) number K043282.

Who is the listed applicant for DEVILBISS AUTOADJUST, MODEL 9054 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 DEVILBISS AUTOADJUST, MODEL 9054 SERIES?

The FDA product code for DEVILBISS AUTOADJUST, MODEL 9054 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.

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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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