The following data is part of a premarket notification filed by Nk Biotechnical Engineering Co. with the FDA for Nk Digi-grip Sensor, Model Dgr001.
| Device ID | K923963 |
| 510k Number | K923963 |
| Device Name: | NK DIGI-GRIP SENSOR, MODEL DGR001 |
| Classification | Dynamometer, Ac-powered |
| Applicant | NK BIOTECHNICAL ENGINEERING CO. P.O. BOX 26335 Minneapolis, MN 55426 |
| Contact | Karen Gotfredson |
| Correspondent | Karen Gotfredson NK BIOTECHNICAL ENGINEERING CO. P.O. BOX 26335 Minneapolis, MN 55426 |
| Product Code | LBB |
| CFR Regulation Number | 888.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-07 |
| Decision Date | 1993-03-31 |