FDA 510(k)

SPIROMETER 210/211

K-Number: K812039 · 1981-09-25

ApplicantMedix Medical Electronics (U.S.A.), Inc.

Decision Date1981-09-25

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SPIROMETER 210/211 is the device name listed in this FDA 510(k) record. The listed applicant is Medix Medical Electronics (U.S.A.), Inc.. It received FDA 510(k) clearance on 1981-09-25 under 510(k) number K812039. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROMETER 210/211?

SPIROMETER 210/211 is a medical device that received FDA 510(k) clearance on 1981-09-25. The listed applicant is Medix Medical Electronics (U.S.A.), Inc.. The 510(k) number is K812039.

When did SPIROMETER 210/211 receive FDA 510(k) clearance?

SPIROMETER 210/211 received FDA 510(k) clearance on 1981-09-25, under 510(k) number K812039.

Who is the listed applicant for SPIROMETER 210/211?

The FDA 510(k) record lists Medix Medical Electronics (U.S.A.), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIROMETER 210/211?

The FDA product code for SPIROMETER 210/211 is BZG.

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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.