FDA 510(k)

FRC 85 SERIES SPIROMETER

K-Number: K840929 · 1984-05-14

ApplicantMedical Equipment Designs, Inc.

Decision Date1984-05-14

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

FRC 85 SERIES SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Equipment Designs, Inc.. It received FDA 510(k) clearance on 1984-05-14 under 510(k) number K840929. 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 FRC 85 SERIES SPIROMETER?

FRC 85 SERIES SPIROMETER is a medical device that received FDA 510(k) clearance on 1984-05-14. The listed applicant is Medical Equipment Designs, Inc.. The 510(k) number is K840929.

When did FRC 85 SERIES SPIROMETER receive FDA 510(k) clearance?

FRC 85 SERIES SPIROMETER received FDA 510(k) clearance on 1984-05-14, under 510(k) number K840929.

Who is the listed applicant for FRC 85 SERIES SPIROMETER?

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

What is the FDA product code for FRC 85 SERIES SPIROMETER?

The FDA product code for FRC 85 SERIES SPIROMETER is BZG.

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Other records listing Medical Equipment Designs, Inc. as applicant

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Related Devices (Code: 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.