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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device extracranial positional system for a transcranial magnetic stimulation system
Regulation Description Stereotaxic instrument.
Definition Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system.
Product CodeSGE
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
ZETA SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

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