The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for B Smart Model 1.
| Device ID | K961817 |
| 510k Number | K961817 |
| Device Name: | B SMART MODEL 1 |
| Classification | Device, Sleep Assessment |
| Applicant | KOVEN TECHNOLOGY, INC. 300 BROOKES DR. SUITE 105 St. Louis, MO 63042 |
| Contact | Paul G Koven |
| Correspondent | Paul G Koven KOVEN TECHNOLOGY, INC. 300 BROOKES DR. SUITE 105 St. Louis, MO 63042 |
| Product Code | LEL |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-10 |
| Decision Date | 1997-07-23 |
| Summary: | summary |