QFLOW 500 PERFUSION MONITORING SYSTEM— 510(k) K013376

Name: FDA 510(k) clearance K013376
Creator: U.S. Food and Drug Administration
Published: 2002-05-08

Substantially Equivalent

Hemedex Incorporated

FDA 510(k) clearance K013376 for QFLOW 500 PERFUSION MONITORING SYSTEM, Substantially Equivalent on 2002-05-08. Applicant: Hemedex Incorporated. Device class: 2.

Clearance details

Applicant: Hemedex Incorporated
Product code: Code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 2001-10-11
Decision date: 2002-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkonton, MA, US

Download summary PDF View on FDA.gov ↗

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