Cleared Special

K060123 - LEVELERT II FLUID LEVEL SENSOR
(FDA 510(k) Clearance)

K060123 · Smith & Nephew, Inc. · General Hospital
Feb 2006
Decision
27d
Days
Class 2
Risk

K060123 is an FDA 510(k) clearance for the LEVELERT II FLUID LEVEL SENSOR, a Monitor, Electric For Gravity Flow Infusion Systems (Class II — Special Controls, product code FLN), submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on February 14, 2006, 27 days after receiving the submission on January 18, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2420.

Submission Details

510(k) Number K060123 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2006
Decision Date February 14, 2006
Days to Decision 27 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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