The following data is part of a premarket notification filed by Electro Medical Systems Sa with the FDA for Swiss Lithoclast Lithotripter.
| Device ID | K951531 |
| 510k Number | K951531 |
| Device Name: | SWISS LITHOCLAST LITHOTRIPTER |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | James R Veale |
| Correspondent | James R Veale ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-03 |
| Decision Date | 1995-08-24 |