VITALOGRAPH MODEL 7000 SPIROTRAC— 510(k) K141546

Name: FDA 510(k) clearance K141546
Creator: U.S. Food and Drug Administration
Published: 2014-09-03

Substantially Equivalent

Vitalograph (Ireland) , Ltd.

FDA 510(k) clearance K141546 for VITALOGRAPH MODEL 7000 SPIROTRAC, Substantially Equivalent on 2014-09-03. Applicant: Vitalograph (Ireland) , Ltd.. Device class: 2.

Clearance details

Applicant: Vitalograph (Ireland) , Ltd.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2014-06-10
Decision date: 2014-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ennis, Co. Clare, IE

Download summary PDF View on FDA.gov ↗

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