FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

ADVANTAGE

K Number: K885246 · Decision Feb 27, 1989
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
138
Applicant Total
2
Review Days
67

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Basic Information

Device Name
ADVANTAGE
K Number
K885246
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.1870
Medical Specialty
Neurology
Decision
Substantially Equivalent
Applicant
Clark Davis Medical Systems, Inc.
Date Received
December 22, 1988
Decision Date
February 27, 1989
Product Code
GWF
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
GWF Stimulator, Electrical, Evoked Response

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Other Clearances by Clark Davis Medical Systems, Inc.

K Number Device Name
K903734 ADVANTAGE EP