Ged (Graduated Electronic Decelerator

FDA 510(k) K911820 · Behavior Research Institute, Inc.

Substantially Equivalent

510(k) numberK911820

Submission

Device name
Ged (Graduated Electronic Decelerator
Applicant
Behavior Research Institute, Inc.
Providence, RI, US
Received
April 24, 1991
Decision date
December 5, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HCB – Device, Aversive Conditioning
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5235
Specialty
Neurology

Other 510(k)s with product code HCB

510(k)DeviceApplicantDecision
K871158Sibis Remote ActuatorHCB · Traditional Human Technologies, Inc.05/29/1987SE
K853178Sibis Self Injurious Behavior Inhibiting SystemHCB · Traditional Oxford Medilog, Inc.02/28/1986SE
K820622Electrostimuli Aversion MachineHCB · Traditional Michael R. Kiss04/09/1982SE
K790738HabitsabaterHCB · Traditional Jackson Ent.06/20/1979SE
K760166Stimulator, Sonic Control (AS-1)HCB · Traditional Farrall Instruments, Inc.07/20/1976SE

Questions and answers

When was Ged (Graduated Electronic Decelerator cleared by the FDA?

Ged (Graduated Electronic Decelerator (K911820) received a 510(k) decision of Substantially Equivalent on December 5, 1994, 1,321 days after the submission was received.

What is the product code of K911820?

The FDA product code is HCB – Device, Aversive Conditioning, a Class II (moderate risk) device regulated under 21 CFR 882.5235.