Cleared Special

M2376A DEVICELINK SYSTEM, MODEL M2376A

K011578 · Agilent Technologies, Inc. · Cardiovascular

Jun 2001

Decision

17d

Days

Class 2

Risk

About This 510(k) Submission

K011578 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 June 8, 2001, 17 days after receiving the submission on May 22, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K011578 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2001
Decision Date	June 08, 2001
Days to Decision	17 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