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FDA 510(k)

PULMOMETER

K-Number: K831803 · 1984-04-30

Decision Date1984-04-30
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Kinetics Measurement Corp.. It received FDA 510(k) clearance on 1984-04-30 under 510(k) number K831803. 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 PULMOMETER?

PULMOMETER is a medical device that received FDA 510(k) clearance on 1984-04-30. The listed applicant is Kinetics Measurement Corp.. The 510(k) number is K831803.

When did PULMOMETER receive FDA 510(k) clearance?

PULMOMETER received FDA 510(k) clearance on 1984-04-30, under 510(k) number K831803.

Who is the listed applicant for PULMOMETER?

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

What is the FDA product code for PULMOMETER?

The FDA product code for PULMOMETER is BZG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: BZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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