The following data is part of a premarket notification filed by Electro Medical Systems Sa with the FDA for Ems Swiss Lithoclast Master (a.k.a. Swiss Lithoclast Ultra).
| Device ID | K012445 |
| 510k Number | K012445 |
| Device Name: | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-01 |
| Decision Date | 2001-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353116101 | K012445 | 000 |
| 07613353000363 | K012445 | 000 |
| 07613353000356 | K012445 | 000 |
| 07613353178604 | K012445 | 000 |
| 07613353204648 | K012445 | 000 |
| 07613353062897 | K012445 | 000 |
| 07613353062309 | K012445 | 000 |
| 07613353062453 | K012445 | 000 |
| 07613353062378 | K012445 | 000 |
| 07613353001964 | K012445 | 000 |
| 07613353000394 | K012445 | 000 |
| 07613353000448 | K012445 | 000 |
| 07613353116095 | K012445 | 000 |
| 07613353116088 | K012445 | 000 |
| 07613353116071 | K012445 | 000 |
| 07613353116064 | K012445 | 000 |
| 07613353116019 | K012445 | 000 |
| 07613353002824 | K012445 | 000 |
| 07613353002817 | K012445 | 000 |
| 07613353002800 | K012445 | 000 |
| 07613353002794 | K012445 | 000 |
| 07613353001940 | K012445 | 000 |