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FDA 510(k)

POSITIVE DISPLACEMENT SPIROMETER

K-Number: K760971 · 1976-12-09

ApplicantBoehringer Laboratories
Decision Date1976-12-09
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POSITIVE DISPLACEMENT SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Laboratories. It received FDA 510(k) clearance on 1976-12-09 under 510(k) number K760971. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POSITIVE DISPLACEMENT SPIROMETER?

POSITIVE DISPLACEMENT SPIROMETER is a medical device that received FDA 510(k) clearance on 1976-12-09. The listed applicant is Boehringer Laboratories. The 510(k) number is K760971.

When did POSITIVE DISPLACEMENT SPIROMETER receive FDA 510(k) clearance?

POSITIVE DISPLACEMENT SPIROMETER received FDA 510(k) clearance on 1976-12-09, under 510(k) number K760971.

Who is the listed applicant for POSITIVE DISPLACEMENT SPIROMETER?

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

What is the FDA product code for POSITIVE DISPLACEMENT SPIROMETER?

The FDA product code for POSITIVE DISPLACEMENT SPIROMETER is BZK.

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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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