ACUITY CENTRAL STATION

Monitor, St Segment With Alarm

PROTOCOL SYSTEMS, INC.

The following data is part of a premarket notification filed by Protocol Systems, Inc. with the FDA for Acuity Central Station.

Pre-market Notification Details

Device IDK972121
510k NumberK972121
Device Name:ACUITY CENTRAL STATION
ClassificationMonitor, St Segment With Alarm
Applicant PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton,  OR  97008 -7101
ContactJames P Welch
CorrespondentJames P Welch
PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton,  OR  97008 -7101
Product CodeMLD  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-05
Decision Date1997-11-07
Summary:summary

NIH GUDID Devices

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