The following data is part of a premarket notification filed by Zimmer Elektromedizin Gmbh with the FDA for Thermo Shortwave Diathermy.
| Device ID | K852166 |
| 510k Number | K852166 |
| Device Name: | THERMO SHORTWAVE DIATHERMY |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | ZIMMER ELEKTROMEDIZIN GMBH JUNKERSSTRABE 9 POSTFACH 22 80 7910 Neu-ulm, Germany, DE |
| Contact | Detlef Gansera |
| Correspondent | Detlef Gansera ZIMMER ELEKTROMEDIZIN GMBH JUNKERSSTRABE 9 POSTFACH 22 80 7910 Neu-ulm, Germany, DE |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-20 |
| Decision Date | 1985-09-30 |