K914059 is an FDA 510(k) clearance for the NK DEVIATION SENSOR, MODEL DV001. This device is classified as a Dynamometer, Ac-powered (Class II - Special Controls, product code LBB).
Submitted by Nk Biotechnical Engineering Co. (Minneapolis, US). The FDA issued a Cleared decision on December 9, 1991, 90 days after receiving the submission on September 10, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1240.
| 510(k) Number | K914059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1991 |
| Decision Date | December 09, 1991 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | LBB — Dynamometer, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.1240 |