Cleared Special

MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A

K001776 · Agilent Technologies, Inc. · Cardiovascular

Jun 2000

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K001776 is an FDA 510(k) clearance for the MODIFICATION TO 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 June 30, 2000, 30 days after receiving the submission on May 31, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K001776 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2000
Decision Date	June 30, 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