ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN— 510(k) K042058

Name: FDA 510(k) clearance K042058
Creator: U.S. Food and Drug Administration
Published: 2005-03-23

Substantially Equivalent

Clement Clarke Intl., Ltd.

FDA 510(k) clearance K042058 for ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN, Substantially Equivalent on 2005-03-23. Applicant: Clement Clarke Intl., Ltd.. Device class: 2.

Clearance details

Applicant: Clement Clarke Intl., Ltd.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2004-07-30
Decision date: 2005-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harlow, GB

Download summary PDF View on FDA.gov ↗

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