Cleared Traditional

MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM

K131247 · Mfs - Medical Flow Systems, Ltd. · General Hospital

Aug 2013

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K131247 is an FDA 510(k) clearance for the MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM, a Pump, Infusion, Elastomeric (Class II — Special Controls, product code MEB), submitted by Mfs - Medical Flow Systems, Ltd. (Shlomi, IL). The FDA issued a Cleared decision on August 14, 2013, 105 days after receiving the submission on May 1, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K131247 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2013
Decision Date	August 14, 2013
Days to Decision	105 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF