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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