FUKUDA SANGYO MODEL SPIROANALYZER ST-180— 510(k) K943546

Name: FDA 510(k) clearance K943546
Creator: U.S. Food and Drug Administration
Published: 1995-02-23

Substantially Equivalent

Spirosoft Northamerica, Inc.

FDA 510(k) clearance K943546 for FUKUDA SANGYO MODEL SPIROANALYZER ST-180, Substantially Equivalent on 1995-02-23. Applicant: Spirosoft Northamerica, Inc.. Device class: 2.

Clearance details

Applicant: Spirosoft Northamerica, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 1994-07-21
Decision date: 1995-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

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