Cleared Special

M2376A DEVICELINK SYSTEM, MODEL M2376A

K003622 · Agilent Technologies, Inc. · Cardiovascular

Dec 2000

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K003622 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 December 18, 2000, 24 days after receiving the submission on November 24, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K003622 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2000
Decision Date	December 18, 2000
Days to Decision	24 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