DSXL DIFFUSION SPIROMETER— 510(k) K961252

Substantially Equivalent

Inair , Ltd.

FDA 510(k) clearance K961252 for DSXL DIFFUSION SPIROMETER, Substantially Equivalent on 1997-02-14. Applicant: Inair , Ltd.. Device class: 2.

Clearance details

Applicant: Inair , Ltd.
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 1996-04-01
Decision date: 1997-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delmar, NY, US

Download summary PDF View on FDA.gov ↗

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