CLINDATALINK VERSION 1.0 FOR SPIROMETRY— 510(k) K020004

Name: FDA 510(k) clearance K020004
Creator: U.S. Food and Drug Administration
Published: 2002-07-24

Substantially Equivalent

Compleware Corp.

FDA 510(k) clearance K020004 for CLINDATALINK VERSION 1.0 FOR SPIROMETRY, Substantially Equivalent on 2002-07-24. Applicant: Compleware Corp.. Device class: 2.

Clearance details

Applicant: Compleware Corp.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2002-01-02
Decision date: 2002-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Iowa City, IA, US

Download summary PDF View on FDA.gov ↗

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