Cleared Special

K014181 - M2376A DEVICELINK SYSTEM, MODEL M2376A (FDA 510(k) Clearance)

K014181 · Philips Medical Systems, Inc. · Cardiovascular device

Jan 2002

Decision

26d

Days

Class 2

Risk

K014181 is an FDA 510(k) clearance for the M2376A DEVICELINK SYSTEM, MODEL M2376A. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).

Submitted by Philips Medical Systems, Inc. (Andover, US). The FDA issued a Cleared decision on January 15, 2002, 26 days after receiving the submission on December 20, 2001.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K014181 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 20, 2001
Decision Date	January 15, 2002
Days to Decision	26 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 870.2300