Cleared Abbreviated

K100420 - PHILIPS OBTRACEVUE MODEL SW REV. G.00 (FDA 510(k) Clearance)

K100420 · Philips Medizin Systeme Boeblingen GmbH · Obstetrics & Gynecology device

Jul 2010

Decision

160d

Days

Class 2

Risk

K100420 is an FDA 510(k) clearance for the PHILIPS OBTRACEVUE MODEL SW REV. G.00. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on July 26, 2010, 160 days after receiving the submission on February 16, 2010.

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

Submission Details

510(k) Number	K100420 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 16, 2010
Decision Date	July 26, 2010
Days to Decision	160 days
Submission Type	Abbreviated
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF