Case 8000 Exercise Testing System
FDA 510(k) K991014 · General Electric Medical Systems Information Techn
510(k) numberK991014
Submission
- Device name
- Case 8000 Exercise Testing System
- Applicant
- General Electric Medical Systems Information Techn
Milwaukee, WI, US - Received
- March 26, 1999
- Decision date
- October 20, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
No product code recorded.
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Questions and answers
When was Case 8000 Exercise Testing System cleared by the FDA?
Case 8000 Exercise Testing System (K991014) received a 510(k) decision of Substantially Equivalent on October 20, 1999, 208 days after the submission was received.