FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

CANMED 103

K Number: K844098 · Decision Feb 4, 1985
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
475
Review Days
104

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Basic Information

Device Name
CANMED 103
K Number
K844098
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.1320
Medical Specialty
Neurology
Decision
Substantially Equivalent
Applicant
Medtronic Vascular
Date Received
October 23, 1984
Decision Date
February 4, 1985
Product Code
GXY
Advisory Committee
Neurology
Review Advisory Committee
NE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GXY Electrode, Cutaneous

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