Cleared Special

M2376A DEVICELINK SYSTEM

K010453 · Agilent Technologies, Inc. · Cardiovascular

Mar 2001

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K010453 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 March 2, 2001, 15 days after receiving the submission on February 15, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K010453 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 2001
Decision Date	March 02, 2001
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