Cleared Special

K033680 - M2376A PHILIPS DEVICE LINK SYSTEM (FDA 510(k) Clearance)

K033680 · Philips Medical Systems · Cardiovascular device

Dec 2003

Decision

17d

Days

Class 2

Risk

K033680 is an FDA 510(k) clearance for the M2376A PHILIPS DEVICE LINK SYSTEM. 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 (Boblingen, DE). The FDA issued a Cleared decision on December 11, 2003, 17 days after receiving the submission on November 24, 2003.

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

Submission Details

510(k) Number	K033680 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 24, 2003
Decision Date	December 11, 2003
Days to Decision	17 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