SPIRO-MASTER PC-10 SPIROMETRY SYSTEM— 510(k) K080921

Name: FDA 510(k) clearance K080921
Creator: U.S. Food and Drug Administration
Published: 2009-01-21

Substantially Equivalent

Chest M.I., Inc.

FDA 510(k) clearance K080921 for SPIRO-MASTER PC-10 SPIROMETRY SYSTEM, Substantially Equivalent on 2009-01-21. Applicant: Chest M.I., Inc.. Device class: 2.

Clearance details

Applicant: Chest M.I., Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2008-04-01
Decision date: 2009-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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