Cleared Special

AGILENT M2636B TELEMON B MONITOR (TELEMON B)

K011824 · Agilent Technologies, Inc. · Cardiovascular
Jul 2001
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K011824 is an FDA 510(k) clearance for the AGILENT M2636B TELEMON B MONITOR (TELEMON B), a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Agilent Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on July 2, 2001, 21 days after receiving the submission on June 11, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K011824 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2001
Decision Date July 02, 2001
Days to Decision 21 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSI — Detector And Alarm, Arrhythmia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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