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FDA 510(k)

INCENTIVE SPIROMETER

K-Number: K760762 · 1976-10-08

ApplicantI-Spiron
Decision Date1976-10-08
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INCENTIVE SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is I-Spiron. It received FDA 510(k) clearance on 1976-10-08 under 510(k) number K760762. 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 INCENTIVE SPIROMETER?

INCENTIVE SPIROMETER is a medical device that received FDA 510(k) clearance on 1976-10-08. The listed applicant is I-Spiron. The 510(k) number is K760762.

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

INCENTIVE SPIROMETER received FDA 510(k) clearance on 1976-10-08, under 510(k) number K760762.

Who is the listed applicant for INCENTIVE SPIROMETER?

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

What is the FDA product code for INCENTIVE SPIROMETER?

The FDA product code for INCENTIVE SPIROMETER is BWF.

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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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