Cleared Traditional

WELCH ALLYN 1500 PATIENT MONITOR

K101619 · Schiller AG · Cardiovascular
Nov 2010
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K101619 is an FDA 510(k) clearance for the WELCH ALLYN 1500 PATIENT MONITOR, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Schiller AG (Baar, CH). The FDA issued a Cleared decision on November 12, 2010, 156 days after receiving the submission on June 9, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K101619 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2010
Decision Date November 12, 2010
Days to Decision 156 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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