The following data is part of a premarket notification filed by Nk Biotechnical Corp. with the FDA for Digit-grip With Lcd, Model Number Dgr 002.
| Device ID | K981730 |
| 510k Number | K981730 |
| Device Name: | DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 |
| Classification | Dynamometer, Ac-powered |
| Applicant | NK BIOTECHNICAL CORP. 10850 OLD COUNTY RD. 15 Minneapolis, MN 55441 |
| Contact | Karen Gotfredson |
| Correspondent | Karen Gotfredson NK BIOTECHNICAL CORP. 10850 OLD COUNTY RD. 15 Minneapolis, MN 55441 |
| Product Code | LBB |
| CFR Regulation Number | 888.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-15 |
| Decision Date | 1998-07-17 |