The following data is part of a premarket notification filed by Ems Electro Medical Systems Sa with the FDA for Swiss Lithoclast Trilogy.
Device ID | K182490 |
510k Number | K182490 |
Device Name: | Swiss LithoClast Trilogy |
Classification | Lithotriptor, Ultrasonic |
Applicant | EMS Electro Medical Systems SA Ch De La 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 | 2018-09-11 |
Decision Date | 2018-10-09 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SWISS LITHOCLAST TRILOGY 79210552 not registered Live/Pending |
EMS Electro Medical Systems GmbH 2017-04-28 |