The following data is part of a premarket notification filed by Nemectron Medical, Inc. with the FDA for Thermopuls E.
| Device ID | K844416 |
| 510k Number | K844416 |
| Device Name: | THERMOPULS E |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| 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 | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-14 |
| Decision Date | 1985-03-12 |