SPIROMETRICS MODEL 2500 FLOWMATE(TM)— 510(k) K863953

Name: FDA 510(k) clearance K863953
Creator: U.S. Food and Drug Administration
Published: 1987-01-15

Substantially Equivalent

Spirometrics, Inc.

FDA 510(k) clearance K863953 for SPIROMETRICS MODEL 2500 FLOWMATE(TM), Substantially Equivalent on 1987-01-15. Applicant: Spirometrics, Inc.. Device class: 2.

Clearance details

Applicant: Spirometrics, Inc.
Product code: Code BZM
Device class: Class 2
Regulation: 21 CFR 868.1900
Advisory panel: Anesthesiology
Date received: 1986-10-10
Decision date: 1987-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, VA, US

Download summary PDF View on FDA.gov ↗

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