K923963 is an FDA 510(k) clearance for the NK DIGI-GRIP SENSOR, MODEL DGR001. 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 March 31, 1993, 236 days after receiving the submission on August 7, 1992.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1240.
| 510(k) Number | K923963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1992 |
| Decision Date | March 31, 1993 |
| Days to Decision | 236 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 |