MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM

Detector And Alarm, Arrhythmia

WELCH ALLYN PROTOCOL, INC.

The following data is part of a premarket notification filed by Welch Allyn Protocol, Inc. with the FDA for Modification To Acuity Central Monitoring System.

Pre-market Notification Details

Device IDK022453
510k NumberK022453
Device Name:MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
ClassificationDetector And Alarm, Arrhythmia
Applicant WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE Beaverton,  OR  97008 -7107
ContactDon M Abbey
CorrespondentDon M Abbey
WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE Beaverton,  OR  97008 -7107
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-26
Decision Date2002-08-21
Summary:summary

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