The following data is part of a premarket notification filed by Zimmer Elektromedizin Gmbh with the FDA for Sono 5.
| Device ID | K952536 |
| 510k Number | K952536 |
| Device Name: | SONO 5 |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | ZIMMER ELEKTROMEDIZIN GMBH 9 JUNKERSSTRABE D7910 Neu-ulm, DE |
| Contact | Duchess Granger |
| Correspondent | Duchess Granger ZIMMER ELEKTROMEDIZIN GMBH 9 JUNKERSSTRABE D7910 Neu-ulm, DE |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-01 |
| Decision Date | 1996-03-05 |