Cleared Traditional

K023931 - PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A (FDA 510(k) Clearance)

K023931 · Philips Medical Systems, Inc. · Obstetrics & Gynecology device

Feb 2003

Decision

90d

Days

Class 2

Risk

K023931 is an FDA 510(k) clearance for the PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).

Submitted by Philips Medical Systems, Inc. (Da Best, NL). The FDA issued a Cleared decision on February 24, 2003, 90 days after receiving the submission on November 26, 2002.

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

Submission Details

510(k) Number	K023931 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 26, 2002
Decision Date	February 24, 2003
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF