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FDA 510(k)

DRAGER DVE 4000 SERIES SYSTEM

K-Number: K921297 · 1992-11-27

ApplicantAlm Surgical Equipment, Inc.
Decision Date1992-11-27
Product CodeFQO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRAGER DVE 4000 SERIES SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alm Surgical Equipment, Inc.. It received FDA 510(k) clearance on 1992-11-27 under 510(k) number K921297. The device is classified under product code FQO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRAGER DVE 4000 SERIES SYSTEM?

DRAGER DVE 4000 SERIES SYSTEM is a medical device that received FDA 510(k) clearance on 1992-11-27. The listed applicant is Alm Surgical Equipment, Inc.. The 510(k) number is K921297.

When did DRAGER DVE 4000 SERIES SYSTEM receive FDA 510(k) clearance?

DRAGER DVE 4000 SERIES SYSTEM received FDA 510(k) clearance on 1992-11-27, under 510(k) number K921297.

Who is the listed applicant for DRAGER DVE 4000 SERIES SYSTEM?

The FDA 510(k) record lists Alm Surgical Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRAGER DVE 4000 SERIES SYSTEM?

The FDA product code for DRAGER DVE 4000 SERIES SYSTEM is FQO.

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Other records listing Alm Surgical Equipment, 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.

K982063ALM PRISMALIX (PRX) SURGICAL LIGHTK961886DRAGER GEMINA WALL-MOUNTED WORKPLACEK961742DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEMK945102MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCEK942043DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032EK922409ALM ILLUMINATOR SERIES LIGHT SYSTEM

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Related Devices (Code: FQO)

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.

K240598Maestro System (REF100)Moon SurgicalK221410Maestro PlatformMoon SurgicalK090136STERIS CMAX XLT SURGICAL TABLESTERIS CorporationK972810OPT80 THE TRANSPORTABLE (OPT80)O.P.T. USA, Inc.K971988ALLEN, ULTRA AND SMART SOCKETSAllen Medical Systems, Inc.K971307AMSCO SURGICAL TABLESTERIS Corporation

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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