FDA 510(k)
Substantially Equivalent
🇺🇸 United States
WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L)
K Number: K901619
·
Decision Sep 5, 1991
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
1
Review Days
517
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Basic Information
- Device Name
- WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L)
- K Number
- K901619
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Wex Medical Instrumentation Co.
- Date Received
- April 6, 1990
- Decision Date
- September 5, 1991
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
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