TVS II ELECTRONIC INCENTIVE SPIROMETER— 510(k) K910138

Name: FDA 510(k) clearance K910138
Creator: U.S. Food and Drug Administration
Published: 1991-03-12

Substantially Equivalent

Monaghan Medical Corp.

FDA 510(k) clearance K910138 for TVS II ELECTRONIC INCENTIVE SPIROMETER, Substantially Equivalent on 1991-03-12. Applicant: Monaghan Medical Corp.. Device class: 2.

Clearance details

Applicant: Monaghan Medical Corp.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1991-01-14
Decision date: 1991-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plattsburgh, NY, US

Download summary PDF View on FDA.gov ↗

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