510(k) K020290

DASH 3000/4000 PATIENT MONITOR by General Electric Medical Systems Information Techn — Product Code MHX

K020290 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "DASH 3000/4000 PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on August 14, 2002. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. General Electric Medical Systems Information Techn has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2002
Date Received
January 28, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type