Cleared Special

MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A

K012094 · Agilent Technologies, Inc. · Cardiovascular

Jul 2001

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K012094 is an FDA 510(k) clearance for the MODIFICATION TO DEVICE LINK 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 July 20, 2001, 15 days after receiving the submission on July 5, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K012094 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2001
Decision Date	July 20, 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