SPIROSOFT— 510(k) K031194

Substantially Equivalent

Viasys Healthcare GmbH

FDA 510(k) clearance K031194 for SPIROSOFT, Substantially Equivalent on 2003-07-30. Applicant: Viasys Healthcare GmbH. Device class: 2.

Clearance details

Applicant: Viasys Healthcare GmbH
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2003-04-16
Decision date: 2003-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Yorba Linda, 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.