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

SIEGEN SURFACE ELECTRODES

K Number: K844646 · Decision Dec 11, 1984
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
6
Review Days
12

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Basic Information

Device Name
SIEGEN SURFACE ELECTRODES
K Number
K844646
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.1320
Medical Specialty
Neurology
Decision
Substantially Equivalent
Applicant
Siegen Corp.
Date Received
November 29, 1984
Decision Date
December 11, 1984
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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K Number Device Name
K871964 SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.
K861884 NEUROSCOPE SEEG
K862430 SIEGEN HEADPHONES
K844616 SIEGEN VISUAL STIMULATOR
K843464 SIEGEN NEUROSCOPE