The following data is part of a premarket notification filed by Nk Biotechnical Engineering Co. with the FDA for Nk Pressure-specified Sensory Device, Model Pssd-001.
| Device ID | K934368 |
| 510k Number | K934368 |
| Device Name: | NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 |
| Classification | Device, Vibration Threshold Measurement |
| Applicant | NK BIOTECHNICAL ENGINEERING CO. 10850 OLD COUNTY RD. 15 Minneapolis, MN 55441 |
| Contact | Karen Gotfredson |
| Correspondent | Karen Gotfredson NK BIOTECHNICAL ENGINEERING CO. 10850 OLD COUNTY RD. 15 Minneapolis, MN 55441 |
| Product Code | LLN |
| CFR Regulation Number | 882.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-07 |
| Decision Date | 1994-08-11 |