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510(k) K935444

Device
OCTOSTOP(R) CHAIR (NEW MODEL
Applicant
OCTOSTOP, INC.
510(k) number
K935444
Product code
IXR  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-02
Date received
1993-11-12
Regulation
892.1980
Classification name
Table, Radiographic, Tilting
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEAN A VEZINA
Address
Casier Postal 1476 Succ. St-Laurent Montreal, Qc. CA H4L 4Z1 H4L 4Z1

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IXR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K000412VISION R/F TILTING TABLEVilla Sistemi Medicali S.P.A.2000-04-24
K973039LEGACY/LEGACY-D TABLEGE Medical Systems1997-10-16
K971128CAP-35B III/CINE 275Jamieson Film Co.1997-04-28
K970640PHILIPS EASY DIAGNOSTPhilips Medical Systems North America, Inc.1997-03-21
K965105ELECTROPHYSIOLOGY TILT TABLE MODEL #9660U.S. Imaging Tables, Inc.1997-01-30
K965096FLUOROVIEW SERIES FLUOROSCOPIC TABLESU.S. Imaging Tables, Inc.1997-01-27
K963851TILTING RADIOGRAPHIC TABLE (REMOTE)Acoma Medical Imaging, Inc.1997-01-23
K961022TANGENT VI TABLEFischer Imaging Corp.1996-05-03
K954356COMPAX 90/15EGeneral Electric Co.1995-10-07
K953557SURGICAL C-ARM TABLE, 9610U.S. Imaging Tables, Inc.1995-09-26
K953556VACS TABLE, 9650U.S. Imaging Tables, Inc.1995-09-26
K951176KOORDINAT MSiemens Medical Solutions USA, Inc.1995-04-20
K950981ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650Biodex Medical Systems, Inc.1995-04-03
K950402CORSINI 9090C.A.T. DI Corsini G. & C. Spa1995-03-31
K945842MOBILIX MOBILE X-RAY TABLEGE Medical Systems1995-01-18

Legacy Summary#

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FDA Review#

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