FDA 510(k) Applications for Medical Device Product Code "BTX"
(Board, Arm (With Cover), Sterile)

FDA 510(k) Number Applicant Device Name Decision Date
K864670 ANAGO, INC. BOARD, ARM (WITH COVER) 01/12/1987
K811419 DATAMED, INC. "SPRIO-LOOP" 06/12/1981
K881292 EDGEWATER MEDICAL SYSTEMS, INC. ALLEN LATERAL ARMBOARD 04/07/1988
K884838 EDGEWATER MEDICAL SYSTEMS, INC. ALLEN PRONE ARMBOARD 12/15/1988
K781233 FIBRE FORMATIONS, INC. IV ARMBOARDS 08/14/1978
K830018 HARVEY A. TURNER, M.D. SAFE-T ARM BOARD 01/26/1983
K900175 INFECTION CONTROL PRODUCTS, INC. 4/1 ARMBOARD 01/24/1990
K882524 KARLIN TECHNOLOGY, INC. UNIVERSALLY ADJUSTABLE ARMBOARD 07/08/1988
K792147 MEDICAL INNOVATIONS CORP. ARM SHIELD FOR ANESTHESIA 12/06/1979
K770391 PRECEPT, INC. COVER, ARMBOARD, DISPOSABLE 03/07/1977
K833664 RICK ROBBIN & FREDERICK AUERBACH ARMBOARD AND THE BOARD 12/27/1983
K823412 SAGE PRODUCTS, INC. ARM BOARD W/I.V COVERING 12/15/1982
K935098 SENTRY MEDICAL PRODUCTS, INC. BABY BOARD 02/15/1994


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