FDA 510(k)

AIRLIFE ELECTRONIC INCENTIVE SPIROMETER

K-Number: K851334 · 1985-08-06

Decision Date1985-08-06

Product CodeBWF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

AIRLIFE ELECTRONIC INCENTIVE SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1985-08-06 under 510(k) number K851334. 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 AIRLIFE ELECTRONIC INCENTIVE SPIROMETER?

AIRLIFE ELECTRONIC INCENTIVE SPIROMETER is a medical device that received FDA 510(k) clearance on 1985-08-06. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K851334.

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

AIRLIFE ELECTRONIC INCENTIVE SPIROMETER received FDA 510(k) clearance on 1985-08-06, under 510(k) number K851334.

Who is the listed applicant for AIRLIFE ELECTRONIC INCENTIVE SPIROMETER?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIRLIFE ELECTRONIC INCENTIVE SPIROMETER?

The FDA product code for AIRLIFE 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.