MICRO DIARY SPIROMETER— 510(k) K100928

Name: FDA 510(k) clearance K100928
Creator: U.S. Food and Drug Administration
Published: 2011-03-07

Substantially Equivalent

Viasys Respiratory Care, Inc.

FDA 510(k) clearance K100928 for MICRO DIARY SPIROMETER, Substantially Equivalent on 2011-03-07. Applicant: Viasys Respiratory Care, Inc.. Device class: 2.

Clearance details

Applicant: Viasys Respiratory Care, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2010-04-05
Decision date: 2011-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

Download summary PDF View on FDA.gov ↗

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