Cleared Traditional

K143695 - CENTRAL MONITORING SYSTEM (FDA 510(k) Clearance)

K143695 · Edan Instruments, Inc. · Obstetrics & Gynecology device

Mar 2015

Decision

96d

Days

Class 2

Risk

K143695 is an FDA 510(k) clearance for the CENTRAL MONITORING SYSTEM. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on March 30, 2015, 96 days after receiving the submission on December 24, 2014.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2740.

Submission Details

510(k) Number	K143695 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 24, 2014
Decision Date	March 30, 2015
Days to Decision	96 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF