Swiss LithoClast Trilogy
Lithotriptor, Ultrasonic
EMS Electro Medical Systems SA
The following data is part of a premarket notification filed by Ems Electro Medical Systems Sa with the FDA for Swiss Lithoclast Trilogy.
Pre-market Notification Details
| Device ID | K181364 |
| 510k Number | K181364 |
| Device Name: | Swiss LithoClast Trilogy |
| Classification | Lithotriptor, Ultrasonic |
| Applicant | EMS Electro Medical Systems SA Ch Dela Vuarpilliere Nyon, CH 1260 |
| Contact | Sonia Callegaro |
| Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002 |
| Product Code | FEO |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-23 |
| Decision Date | 2018-06-20 |
| Summary: | summary |
Trademark Results [Swiss LithoClast Trilogy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SWISS LITHOCLAST TRILOGY 79210552 not registered Live/Pending |
EMS Electro Medical Systems GmbH 2017-04-28 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.