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FDA 510(k)

TVS II ELECTRONIC INCENTIVE SPIROMETER

K-Number: K910138 · 1991-03-12

ApplicantMonaghan Medical Corp.
Decision Date1991-03-12
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TVS II ELECTRONIC INCENTIVE SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Monaghan Medical Corp.. It received FDA 510(k) clearance on 1991-03-12 under 510(k) number K910138. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TVS II ELECTRONIC INCENTIVE SPIROMETER?

TVS II ELECTRONIC INCENTIVE SPIROMETER is a medical device that received FDA 510(k) clearance on 1991-03-12. The listed applicant is Monaghan Medical Corp.. The 510(k) number is K910138.

When did TVS II ELECTRONIC INCENTIVE SPIROMETER receive FDA 510(k) clearance?

TVS II ELECTRONIC INCENTIVE SPIROMETER received FDA 510(k) clearance on 1991-03-12, under 510(k) number K910138.

Who is the listed applicant for TVS II ELECTRONIC INCENTIVE SPIROMETER?

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

What is the FDA product code for TVS II ELECTRONIC INCENTIVE SPIROMETER?

The FDA product code for TVS II ELECTRONIC INCENTIVE SPIROMETER is BWF.

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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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