The following data is part of a premarket notification filed by Bell Intl., Inc. with the FDA for Model 45e Handengine & Controller, Model 45eh Handengine & Controller, Model Rx-100 Handengine & Controller, Model Eteln.
| Device ID | K964863 |
| 510k Number | K964863 |
| Device Name: | MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | BELL INTL., INC. 31 EDWARDS CT. Burlingame, CA 94010 |
| Contact | Dewey Bell |
| Correspondent | Dewey Bell BELL INTL., INC. 31 EDWARDS CT. Burlingame, CA 94010 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-04 |
| Decision Date | 1997-02-28 |
| Summary: | summary |