Cleared Traditional

K040903 - CADENCE, MODELS 2001 AND 2002 (FDA 510(k) Clearance)

K040903 · Edan Instruments, Inc. · Obstetrics & Gynecology device

Sep 2004

Decision

148d

Days

Class 2

Risk

K040903 is an FDA 510(k) clearance for the CADENCE, MODELS 2001 AND 2002. 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 September 2, 2004, 148 days after receiving the submission on April 7, 2004.

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

Submission Details

510(k) Number	K040903 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 07, 2004
Decision Date	September 02, 2004
Days to Decision	148 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF