510(k) K871158
- Device
- SIBIS REMOTE ACTUATOR
- Applicant
- HUMAN TECHNOLOGIES, INC.
- 510(k) number
- K871158
- Product code
- HCB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-05-29
- Date received
- 1987-03-24
- Regulation
- 882.5235
- Classification name
- Device, Aversive Conditioning
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES N DEERING
- Address
- 1325 Snell Isle Blvd. NE St. Petersburg FL US 33704 33704
FDA Registration Numbers#
- 1222743
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HCB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K911820 | GED (GRADUATED ELECTRONIC DECELERATOR | Behavior Research Institute, Inc. | 1994-12-05 |
| K853178 | SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM | Oxford Medilog, Inc. | 1986-02-28 |
| K820622 | ELECTROSTIMULI AVERSION MACHINE | Michael R. Kiss | 1982-04-09 |
| K790738 | HABITSABATER | Jackson Ent. | 1979-06-20 |
| K760166 | STIMULATOR, SONIC CONTROL (AS-1) | Farrall Instruments, Inc. | 1976-07-20 |
Legacy Summary#
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FDA Review#
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