FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION
K Number: K974199
·
Decision Feb 6, 1998
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
9
Review Days
88
Basic Information
- Device Name
- ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION
- K Number
- K974199
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MARQUETTE MEDICAL SYSTEMS, INC.
- Date Received
- November 10, 1997
- Decision Date
- February 6, 1998
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
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