CMD/DLCO DIAGNOSTIC SPIROMETER— 510(k) K911358

Name: FDA 510(k) clearance K911358
Creator: U.S. Food and Drug Administration
Published: 1991-07-22

Substantially Equivalent

Spirometrics, Inc.

FDA 510(k) clearance K911358 for CMD/DLCO DIAGNOSTIC SPIROMETER, Substantially Equivalent on 1991-07-22. Applicant: Spirometrics, Inc.. Device class: 2.

Clearance details

Applicant: Spirometrics, Inc.
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 1991-03-28
Decision date: 1991-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auburn, ME, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.