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510(k) K820622

ELECTROSTIMULI AVERSION MACHINE by Michael R. Kiss — Product Code HCB

K820622 is an FDA 510(k) premarket notification submitted by Michael R. Kiss for the device "ELECTROSTIMULI AVERSION MACHINE". The FDA issued a decision of Substantially Equivalent on April 9, 1982. The device falls under product code HCB (Device, Aversive Conditioning), a Class II device regulated under 21 CFR 882.5235.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1982
Date Received
March 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Aversive Conditioning
Device Class
Class II
Regulation Number
882.5235
Review Panel
NE
Submission Type

Other clearances for product code HCB

  • K911820 — GED (GRADUATED ELECTRONIC DECELERATOR (December 5, 1994)
  • K871158 — SIBIS REMOTE ACTUATOR (May 29, 1987)
  • K853178 — SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM (February 28, 1986)
  • K790738 — HABITSABATER (June 20, 1979)
  • K760166 — STIMULATOR, SONIC CONTROL (AS-1) (July 20, 1976)

FDA data resources