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510(k) Data Aggregation
K Number
K972810Device Name
OPT80 THE TRANSPORTABLE (OPT80)
Manufacturer
O.P.T. USA, INC.
Date Cleared
1997-08-26
(29 days)
Product Code
FQO
Regulation Number
878.4960Why did this record match?
Applicant Name (Manufacturer) :
O.P.T. USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OPT 80 Mobile Operating Table is designed for use during diagnostic examinations or surgical procedures to support and position a patient. It is made up of a column, movable tabletops and trolley. The tabletops allow trendelenburg, and reverse trendelenburg positioning, lateral tilting as well as back, leg and head plate movement. It has side rails for fitting additional accessories as may be required by a particular procedure. The table system is designed to hold a patient of 180 Kg. (400 Lbs.) in the positions described in the Instruction Manual and the attached Standard Equivalency Table.
Device Description
The OPT 80 Mobile Operating Table is designed for use during diagnostic examinations or surgical procedures to support and position a patient. It is made up of a column, movable tabletops and trolley. The tabletops allow trendelenburg, and reverse trendelenburg positioning, lateral tilting as well as back, leg and head plate movement. It has side rails for fitting additional accessories as may be required by a particular procedure. The table system is designed to hold a patient of 180 Kg. (400 Lbs.) in the positions described in the Instruction Manual and the attached Standard Equivalency Table. There are secondary back-up operating devices to allow operation of the table should the primary control or power supply fail.
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