The following data is part of a premarket notification filed by Behavior Research Institute, Inc. with the FDA for Ged (graduated Electronic Decelerator.
Device ID | K911820 |
510k Number | K911820 |
Device Name: | GED (GRADUATED ELECTRONIC DECELERATOR |
Classification | Device, Aversive Conditioning |
Applicant | BEHAVIOR RESEARCH INSTITUTE, INC. 240 LABAN ST. Providence, RI 02909 |
Contact | Maureen Fogarty |
Correspondent | Maureen Fogarty BEHAVIOR RESEARCH INSTITUTE, INC. 240 LABAN ST. Providence, RI 02909 |
Product Code | HCB |
CFR Regulation Number | 882.5235 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-24 |
Decision Date | 1994-12-05 |