GED (GRADUATED ELECTRONIC DECELERATOR
FDA 510(k) clearance K911820 · decided 1994-12-05
Clearance details
- K-number
- K911820
- Device name
- GED (GRADUATED ELECTRONIC DECELERATOR
- Applicant
- Behavior Research Institute, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-24
- Decision date
- 1994-12-05
- Days to decision
- 1321 days
- Clearance type
- Traditional
- Product code
- HCB
- Device class
- 2
- Regulation number
- 882.5235
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Providence, RI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Behavior Research Institute
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SIBIS REMOTE ACTUATOR (K871158) | Human Technologies, Inc. | 1987-05-29 |
| SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM (K853178) | Oxford Medilog, Inc. | 1986-02-28 |
| ELECTROSTIMULI AVERSION MACHINE (K820622) | Michael R. Kiss | 1982-04-09 |
| HABITSABATER (K790738) | Jackson Ent. | 1979-06-20 |
| STIMULATOR, SONIC CONTROL (AS-1) (K760166) | Farrall Instruments, Inc. | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.