FDA.reportPublic FDA data

510(k) K033335

Device
LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
510(k) number
K033335
Product code
MMZ  
Decision
Substantially Equivalent (SESE)
Decision date
2003-11-25
Date received
2003-10-16
Regulation
876.4890
Classification name
Table, Cystometric, Electric
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DEBBIE PEACOCK
Address
51 Valley Stream Pkwy. Mavern PA US 19355 19355

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MMZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K954278BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005Beta Medical Products, Inc.1995-10-02
K942445SYNERGY IISynectics Medical, Inc.1994-11-22
K942485MDT UROLOGY TABLEMdt Corp., Inc.1994-08-26

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases