Cleared Special

M2376A DEVICELINK SYSTEM

K003107 · Agilent Technologies, Inc. · Cardiovascular

Oct 2000

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K003107 is an FDA 510(k) clearance for the M2376A DEVICELINK SYSTEM, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Agilent Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on October 19, 2000, 15 days after receiving the submission on October 4, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K003107 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 04, 2000
Decision Date	October 19, 2000
Days to Decision	15 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