510(k) K911820
K911820 is an FDA 510(k) premarket notification submitted by Behavior Research Institute, Inc. for the device "GED (GRADUATED ELECTRONIC DECELERATOR". The FDA issued a decision of Substantially Equivalent on December 5, 1994. 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
- December 5, 1994
- Date Received
- April 24, 1991
- 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