Cleared Abbreviated

ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)

K132547 · Monarch Medical Technologies · General Hospital
Apr 2014
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K132547 is an FDA 510(k) clearance for the ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS), a Calculator, Drug Dose (Class II — Special Controls, product code NDC), submitted by Monarch Medical Technologies (Silver Spring, US). The FDA issued a Cleared decision on April 17, 2014, 247 days after receiving the submission on August 13, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K132547 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2013
Decision Date April 17, 2014
Days to Decision 247 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code NDC — Calculator, Drug Dose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890