MODULARIS VARIOSTAR
Lithotriptor, Extracorporeal Shock-wave, Urological
SIEMENS MEDICAL SOLUTIONS USA INC.
The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Modularis Variostar.
Pre-market Notification Details
| Device ID | K070799 |
| 510k Number | K070799 |
| Device Name: | MODULARIS VARIOSTAR |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA INC. 51 VALLEY STREAM PARKWAY MS E50 Malvern, PA 19355 |
| Contact | Kim Rendon |
| Correspondent | Kim Rendon SIEMENS MEDICAL SOLUTIONS USA INC. 51 VALLEY STREAM PARKWAY MS E50 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 | 2007-03-23 |
| Decision Date | 2007-11-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869008974 | K070799 | 000 |
Trademark Results [MODULARIS VARIOSTAR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MODULARIS VARIOSTAR 79018424 3239996 Live/Registered |
Siemens Healthcare GmbH 2005-11-18 |
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