FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CASE 8000 EXERCISE TESTING SYSTEM
K Number: K991014
·
Decision Oct 20, 1999
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
33
Review Days
208
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Basic Information
- Device Name
- CASE 8000 EXERCISE TESTING SYSTEM
- K Number
- K991014
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- General Electric Medical Systems Information Techn
- Date Received
- March 26, 1999
- Decision Date
- October 20, 1999
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
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