510(k) K991014

CASE 8000 EXERCISE TESTING SYSTEM by General Electric Medical Systems Information Techn — Product Code LOS

K991014 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "CASE 8000 EXERCISE TESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 20, 1999. 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 20, 1999
Date Received
March 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No