Cleared Traditional

K100797 - FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS (FDA 510(k) Clearance)

K100797 · Edan Instruments, Inc. · Obstetrics & Gynecology device

Nov 2010

Decision

233d

Days

Class 2

Risk

K100797 is an FDA 510(k) clearance for the FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).

Submitted by Edan Instruments, Inc. (Great Neck, US). The FDA issued a Cleared decision on November 10, 2010, 233 days after receiving the submission on March 22, 2010.

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

Submission Details

510(k) Number	K100797 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 22, 2010
Decision Date	November 10, 2010
Days to Decision	233 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF