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510(k) K830325

TIGER PULSE by Bertone & Assoc. — Product Code GZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1983
Date Received
February 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Nasopharyngeal
Device Class
Class II
Regulation Number
882.1340
Review Panel
NE
Submission Type

Other clearances for product code GZK

  • K030517 — BALL RECORDING ELECTRODE/STIMULATION PROBE (August 1, 2003)