510(k) K991014
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