SPIROBANK PORTABLE PC BASED SPIROMETER— 510(k) K973456

Name: FDA 510(k) clearance K973456
Creator: U.S. Food and Drug Administration
Published: 1998-07-22

Substantially Equivalent

Futuremed America, Inc.

FDA 510(k) clearance K973456 for SPIROBANK PORTABLE PC BASED SPIROMETER, Substantially Equivalent on 1998-07-22. Applicant: Futuremed America, Inc.. Device class: 2.

Clearance details

Applicant: Futuremed America, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 1997-09-11
Decision date: 1998-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Granada Hills, CA, 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.