The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Lithoskop.
| Device ID | K070665 |
| 510k Number | K070665 |
| Device Name: | LITHOSKOP |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MS E-50 Malvern, PA 19355 |
| Contact | Kim Rendon |
| Correspondent | Kim Rendon SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MS E-50 Malvern, PA 19355 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-12 |
| Decision Date | 2008-01-04 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LITHOSKOP 79010168 3127097 Dead/Cancelled |
Siemens Aktiengesellschaft 2005-02-17 |