510(k) K020661

UNITY IS PATIENT VIEWER by General Electric Medical Systems Information Techn — Product Code MSX

K020661 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "UNITY IS PATIENT VIEWER". The FDA issued a decision of Substantially Equivalent on May 24, 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
May 24, 2002
Date Received
March 1, 2002
Clearance Type
Traditional
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