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FDA 510(k)

SPIROMETER, MINI POSITIVE

K-Number: K782145 · 1979-01-31

ApplicantBoehringer Laboratories
Decision Date1979-01-31
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROMETER, MINI POSITIVE is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Laboratories. It received FDA 510(k) clearance on 1979-01-31 under 510(k) number K782145. 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 SPIROMETER, MINI POSITIVE?

SPIROMETER, MINI POSITIVE is a medical device that received FDA 510(k) clearance on 1979-01-31. The listed applicant is Boehringer Laboratories. The 510(k) number is K782145.

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

SPIROMETER, MINI POSITIVE received FDA 510(k) clearance on 1979-01-31, under 510(k) number K782145.

Who is the listed applicant for SPIROMETER, MINI POSITIVE?

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 SPIROMETER, MINI POSITIVE?

The FDA product code for SPIROMETER, MINI POSITIVE 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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