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510(k) K954278

Device
BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005
Applicant
BETA MEDICAL PRODUCTS, INC.
510(k) number
K954278
Product code
MMZ  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-02
Date received
1995-09-13
Regulation
876.4890
Classification name
Table, Cystometric, Electric
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KEVIN BENOIT
Address
530 S. Main St., Bldg. 17 Akron OH US 44311 44311

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MMZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K033335LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUSSiemens Medical Solutions USA, Inc.2003-11-25
K942445SYNERGY IISynectics Medical, Inc.1994-11-22
K942485MDT UROLOGY TABLEMdt Corp., Inc.1994-08-26

Legacy Summary#

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FDA Review#

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