Cleared Traditional

K100358 - CENTRAL MONITORING SYSTEM (FDA 510(k) Clearance)

K100358 · Edan Instruments, Inc. · Obstetrics & Gynecology device

Jan 2011

Decision

328d

Days

Class 2

Risk

K100358 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. (Yonkers, US). The FDA issued a Cleared decision on January 6, 2011, 328 days after receiving the submission on February 12, 2010.

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

Submission Details

510(k) Number	K100358 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 12, 2010
Decision Date	January 06, 2011
Days to Decision	328 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF