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BTX — Board, Arm (With Cover), Sterile Class I

FDA Device Classification

Classification Details

Product Code
BTX
Device Class
Class I
Regulation Number
878.3910
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K935098sentry medical productsBABY BOARDFebruary 15, 1994
K900175infection control products4/1 ARMBOARDJanuary 24, 1990
K884838edgewater medical systemsALLEN PRONE ARMBOARDDecember 15, 1988
K882524karlin technologyUNIVERSALLY ADJUSTABLE ARMBOARDJuly 8, 1988
K881292edgewater medical systemsALLEN LATERAL ARMBOARDApril 7, 1988
K864670anagoBOARD, ARM (WITH COVER)January 12, 1987
K833664rick robbin and frederick auerbachARMBOARD AND THE BOARDDecember 27, 1983
K830018harvey a. turner, m.dSAFE-T ARM BOARDJanuary 26, 1983
K823412sage productsARM BOARD W/I.V COVERINGDecember 15, 1982
K811419datamedSPRIO-LOOPJune 12, 1981
K792147medical innovationsARM SHIELD FOR ANESTHESIADecember 6, 1979
K781233fibre formationsIV ARMBOARDSAugust 14, 1978
K770391preceptCOVER, ARMBOARD, DISPOSABLEMarch 7, 1977