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FDA 510(k)

DRAGER ORMC

K-Number: K800764 · 1980-04-29

ApplicantDraeger Medical, Inc.
Decision Date1980-04-29
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DRAGER ORMC is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical, Inc.. It received FDA 510(k) clearance on 1980-04-29 under 510(k) number K800764. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRAGER ORMC?

DRAGER ORMC is a medical device that received FDA 510(k) clearance on 1980-04-29. The listed applicant is Draeger Medical, Inc.. The 510(k) number is K800764.

When did DRAGER ORMC receive FDA 510(k) clearance?

DRAGER ORMC received FDA 510(k) clearance on 1980-04-29, under 510(k) number K800764.

Who is the listed applicant for DRAGER ORMC?

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

What is the FDA product code for DRAGER ORMC?

The FDA product code for DRAGER ORMC is BZR.

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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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