ISSYS DRUG FLOW MONITOR— 510(k) K050783

Name: FDA 510(k) clearance K050783
Creator: U.S. Food and Drug Administration
Published: 2006-02-22

Substantially Equivalent

Integrated Sensing Systems, Inc.

FDA 510(k) clearance K050783 for ISSYS DRUG FLOW MONITOR, Substantially Equivalent on 2006-02-22. Applicant: Integrated Sensing Systems, Inc.. Device class: 2.

Clearance details

Applicant: Integrated Sensing Systems, Inc.
Product code: Code FLN
Device class: Class 2
Regulation: 21 CFR 880.2420
Advisory panel: General Hospital
Date received: 2005-03-28
Decision date: 2006-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ypsilanti, MI, US

Download summary PDF View on FDA.gov ↗

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