The following data is part of a premarket notification filed by Nemectron Medical, Inc. with the FDA for Nemectrodyn Model 2 & Endovac 2.
| Device ID | K854721 |
| 510k Number | K854721 |
| Device Name: | NEMECTRODYN MODEL 2 & ENDOVAC 2 |
| Classification | Interferential Current Therapy |
| Applicant | NEMECTRON MEDICAL, INC. 28069 DIAZ RD., UNIT A Temecula, CA 92590 |
| Contact | Juergen F Kopf |
| Correspondent | Juergen F Kopf NEMECTRON MEDICAL, INC. 28069 DIAZ RD., UNIT A Temecula, CA 92590 |
| Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-22 |
| Decision Date | 1986-03-06 |