DASH 3000/4000 PATIENT MONITOR

Detector And Alarm, Arrhythmia

GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN

The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Dash 3000/4000 Patient Monitor.

Pre-market Notification Details

Device IDK001359
510k NumberK001359
Device Name:DASH 3000/4000 PATIENT MONITOR
ClassificationDetector And Alarm, Arrhythmia
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee,  WI  53223
ContactDavid Wahlig
CorrespondentDavid Wahlig
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee,  WI  53223
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-28
Decision Date2000-07-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682115773 K001359 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.