The following data is part of a premarket notification filed by Ems Electro Medical Systems Sa with the FDA for Swiss Lithobreaker.
| Device ID | K123038 |
| 510k Number | K123038 |
| Device Name: | SWISS LITHOBREAKER |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | EMS ELECTRO MEDICAL SYSTEMS SA 225 Turnpike Road Southborough, MA 01772 |
| Contact | Suzanne Goodman |
| Correspondent | Suzanne Goodman EMS ELECTRO MEDICAL SYSTEMS SA 225 Turnpike Road Southborough, MA 01772 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2013-01-16 |
| Summary: | summary |