K961817 is an FDA 510(k) clearance for the B SMART MODEL 1. This device is classified as a Device, Sleep Assessment (Class II - Special Controls, product code LEL).
Submitted by Koven Technology, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 23, 1997, 439 days after receiving the submission on May 10, 1996.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K961817 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 1996 |
| Decision Date | July 23, 1997 |
| Days to Decision | 439 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LEL — Device, Sleep Assessment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5050 |