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FDA 510(k)

SIEMENS-ELEMA AB O2-AIR MIXER 960

K-Number: K800905 · 1980-05-08

ApplicantSiemens Elema AB
Decision Date1980-05-08
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SIEMENS-ELEMA AB O2-AIR MIXER 960 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Elema AB. It received FDA 510(k) clearance on 1980-05-08 under 510(k) number K800905. 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 SIEMENS-ELEMA AB O2-AIR MIXER 960?

SIEMENS-ELEMA AB O2-AIR MIXER 960 is a medical device that received FDA 510(k) clearance on 1980-05-08. The listed applicant is Siemens Elema AB. The 510(k) number is K800905.

When did SIEMENS-ELEMA AB O2-AIR MIXER 960 receive FDA 510(k) clearance?

SIEMENS-ELEMA AB O2-AIR MIXER 960 received FDA 510(k) clearance on 1980-05-08, under 510(k) number K800905.

Who is the listed applicant for SIEMENS-ELEMA AB O2-AIR MIXER 960?

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

What is the FDA product code for SIEMENS-ELEMA AB O2-AIR MIXER 960?

The FDA product code for SIEMENS-ELEMA AB O2-AIR MIXER 960 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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