Cleared Traditional

ISSYS DRUG FLOW MONITOR

K050783 · Integrated Sensing Systems, Inc. · General Hospital
Feb 2006
Decision
331d
Days
Class 2
Risk

About This 510(k) Submission

K050783 is an FDA 510(k) clearance for the ISSYS DRUG FLOW MONITOR, a Monitor, Electric For Gravity Flow Infusion Systems (Class II — Special Controls, product code FLN), submitted by Integrated Sensing Systems, Inc. (Ypsilanti, US). The FDA issued a Cleared decision on February 22, 2006, 331 days after receiving the submission on March 28, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2420.

Submission Details

510(k) Number K050783 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2005
Decision Date February 22, 2006
Days to Decision 331 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FLN — Monitor, Electric For Gravity Flow Infusion Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2420