K970870 is an FDA 510(k) clearance for the DIGIT-GRIP WITH LCD (DGR002). This device is classified as a Dynamometer, Nonpowered (Class I - General Controls, product code HRW).
Submitted by Nk Biotechnical Corp. (Minneapolis, US). The FDA issued a Cleared decision on May 2, 1997, 53 days after receiving the submission on March 10, 1997.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1250.
| 510(k) Number | K970870 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1997 |
| Decision Date | May 02, 1997 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HRW — Dynamometer, Nonpowered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.1250 |