FDA.reportPublic FDA data

510(k) K971390

Device
Quantum 3080sp Surgical Table
Applicant
STERIS Corporation
510(k) number
K971390
Product code
GDC
Decision
Substantially Equivalent (SESE)
Decision date
1997-05-15
Date received
1997-04-14
Regulation
878.4960
Classification name
Table, Operating-Room, Electrical
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LORI HALLER
Address
5960 Heisley Rd. Mentor OH US 44060 44060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GDC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970807MOBILE OPERATING TABLE 1132.01Stierlen-Maquet AG1997-03-14
K964273DURA-BOARD ARMBOARDAllen Medical Systems, Inc.1997-01-08
K940616SKYTRON ELITE 3500 TABLESkytron, Div. the Kmw Group, Inc.1994-06-13
K934744MIDMARK MAGNUM GENERAL SURGICAL TABLEMidmark Corp.1994-03-28
K914758MDT/SHAMPAINE MODEL 4900B SURGICAL TABLEMdt Corp., Inc.1991-12-19
K915393MDT/SHAMPAINE MODEL 4900E SURGICAL TABLEMdt Corp., Inc.1991-12-17
K883613OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO.Stierlen-Maquet AG1988-09-15
K853720MOBILE OPERATING TABLE FOR ORL MICROSURGERYCarl Zeiss, Inc.1985-10-18
K853480SKYTRON ELITE 6000 & 6001 SURGICAL TABLESSkytron, Div. the Kmw Group, Inc.1985-09-12
K853535TRAUMA TABLEXre Corp.1985-09-11
K851021MAYFIELD TABLE-ELECTRICOhio Medical Instrument Co., Inc.1985-05-21
K851830SKYTRON ELITE 7000 MICRO-SURGERY TABLESkytron, Div. the Kmw Group, Inc.1985-05-17
K851829SKYTRON ELITE 3100 SURGICAL TABLESkytron, Div. the Kmw Group, Inc.1985-05-17
K850168STILLE SCANDIA OPERATING TABLES RC 3000,1100Stille-Werner (Usa), Inc.1985-03-28
K843134MOBILE OPERATING TABLE HEIDELBERGS 1130Stierlen-Maquet AG1984-09-07