FDA 510(k)

K-MED ENCOURAGER INCENTIVE SPIROMETER

K-Number: K810641 · 1981-05-13

Decision Date1981-05-13

Product CodeBWF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

K-MED ENCOURAGER INCENTIVE SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is K-Med, Inc.. It received FDA 510(k) clearance on 1981-05-13 under 510(k) number K810641. 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 K-MED ENCOURAGER INCENTIVE SPIROMETER?

K-MED ENCOURAGER INCENTIVE SPIROMETER is a medical device that received FDA 510(k) clearance on 1981-05-13. The listed applicant is K-Med, Inc.. The 510(k) number is K810641.

When did K-MED ENCOURAGER INCENTIVE SPIROMETER receive FDA 510(k) clearance?

K-MED ENCOURAGER INCENTIVE SPIROMETER received FDA 510(k) clearance on 1981-05-13, under 510(k) number K810641.

Who is the listed applicant for K-MED ENCOURAGER INCENTIVE SPIROMETER?

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

What is the FDA product code for K-MED ENCOURAGER INCENTIVE SPIROMETER?

The FDA product code for K-MED ENCOURAGER 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.