The following data is part of a premarket notification filed by Casa Futura Technologies with the FDA for Biofeedback System For Speech Disorders.
| Device ID | K942651 |
| 510k Number | K942651 |
| Device Name: | BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS |
| Classification | Device, Anti-stammering |
| Applicant | CASA FUTURA TECHNOLOGIES 18510 DECATUR DR. Monte Sereno, CA 95030 -3088 |
| Contact | Thomas David Kehoe |
| Correspondent | Thomas David Kehoe CASA FUTURA TECHNOLOGIES 18510 DECATUR DR. Monte Sereno, CA 95030 -3088 |
| Product Code | KTH |
| CFR Regulation Number | 874.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-03 |
| Decision Date | 1995-10-19 |