510(k) K020524

PATIENTNET MONITORING SYSTEM by General Electric Medical Systems Information Techn — Product Code MSX

K020524 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "PATIENTNET MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 20, 2002. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. General Electric Medical Systems Information Techn has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2002
Date Received
February 19, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Network And Communication, Physiological Monitors
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type