FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CENTRA HEART STATION
K Number: K935589
·
Decision Aug 24, 1995
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
82
Review Days
644
Basic Information
- Device Name
- CENTRA HEART STATION
- K Number
- K935589
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MARQUETTE ELECTRONICS, INC.
- Date Received
- November 18, 1993
- Decision Date
- August 24, 1995
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
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