Cleared Traditional

M2376A DEVICELINK SYSTEM

K010048 · Agilent Technologies, Inc. · Cardiovascular

Feb 2001

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K010048 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 February 1, 2001, 27 days after receiving the submission on January 5, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K010048 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2001
Decision Date	February 01, 2001
Days to Decision	27 days
Submission Type	Traditional
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