Cleared Special

M2376A DEVICELINK SYSTEM, MODEL M2376A

K010342 · Agilent Technologies, Inc. · Cardiovascular

Feb 2001

Decision

Days

Class 2

Risk

About This 510(k) Submission

K010342 is an FDA 510(k) clearance for the M2376A DEVICELINK SYSTEM, MODEL M2376A, 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 14, 2001, 9 days after receiving the submission on February 5, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K010342 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2001
Decision Date	February 14, 2001
Days to Decision	9 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