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FDA 510(k)

ARGIS PULMONARY FUNCTION TESTING SYSTEM

K-Number: K921306 · 1993-06-25

ApplicantMed Science
Decision Date1993-06-25
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ARGIS PULMONARY FUNCTION TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Med Science. It received FDA 510(k) clearance on 1993-06-25 under 510(k) number K921306. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARGIS PULMONARY FUNCTION TESTING SYSTEM?

ARGIS PULMONARY FUNCTION TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 1993-06-25. The listed applicant is Med Science. The 510(k) number is K921306.

When did ARGIS PULMONARY FUNCTION TESTING SYSTEM receive FDA 510(k) clearance?

ARGIS PULMONARY FUNCTION TESTING SYSTEM received FDA 510(k) clearance on 1993-06-25, under 510(k) number K921306.

Who is the listed applicant for ARGIS PULMONARY FUNCTION TESTING SYSTEM?

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

What is the FDA product code for ARGIS PULMONARY FUNCTION TESTING SYSTEM?

The FDA product code for ARGIS PULMONARY FUNCTION TESTING SYSTEM is BZC.

Related Clinical Trials

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Other records listing Med Science as applicant

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.

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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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