Cleared Special

HP M2376A DEVICE LINK SYSTEM, MODEL M2376A

K002009 · Agilent Technologies, Inc. · Cardiovascular

Aug 2000

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K002009 is an FDA 510(k) clearance for the HP M2376A 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 August 2, 2000, 30 days after receiving the submission on July 3, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K002009 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2000
Decision Date	August 02, 2000
Days to Decision	30 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