510(k) K021454

UNITY NETWORK ID by General Electric Medical Systems Information Techn — Product Code MWI

K021454 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "UNITY NETWORK ID". The FDA issued a decision of Substantially Equivalent on October 1, 2002. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), 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
October 1, 2002
Date Received
May 6, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type