The following data is part of a premarket notification filed by Nissha Medical Technologies Ltd with the FDA for Nissha Medical Technologies Neutral Electrodes.
| Device ID | K203494 |
| 510k Number | K203494 |
| Device Name: | Nissha Medical Technologies Neutral Electrodes |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Nissha Medical Technologies LTD Torbay Business Park, Woodview Road Paignton, GB Tq4 7hp |
| Contact | Marcel Salchner |
| Correspondent | Marcel Salchner Nissha Medical Technologies LTD Torbay Business Park, Woodview Road Paignton, GB Tq4 7hp |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-27 |
| Decision Date | 2021-02-23 |
| Summary: | summary |