HEMOSONIC 200HEMODYNAMIC MONITOR— 510(k) K040802

Name: FDA 510(k) clearance K040802
Creator: U.S. Food and Drug Administration
Published: 2004-04-28

Substantially Equivalent

Arrow Intl., Inc.

FDA 510(k) clearance K040802 for HEMOSONIC 200HEMODYNAMIC MONITOR, Substantially Equivalent on 2004-04-28. Applicant: Arrow Intl., Inc.. Device class: 2.

Clearance details

Applicant: Arrow Intl., Inc.
Product code: Product code DPN
Device class: Class 2
Regulation: 21 CFR 862.3700
Advisory panel: Clinical Toxicology
Date received: 2004-03-29
Decision date: 2004-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Reading, PA, US

Download summary PDF View on FDA.gov ↗

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