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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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510(K)
Number
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Decision
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capenergy c equipment rf system - c25, c50, c100, c200, c300, c400, c500 Capenergy Medical S.L. k222260 03/28/2023
card guard personal electrocardiogram transmitter, model cg-6206/6306 Card Guard Scientific Survival , Ltd. k000225 02/11/2000
cardiac pacing electrode Medi-Dyne Instruments, Inc. k792379 12/05/1979
cardiac pulse generator, model 160b Telectronics, Inc. k780113 02/13/1978
cardiovascular instruments-various Edward Weck, Inc. k791710 09/12/1979
cathscanner(r) pta balloon dilatation catheter Endosonics Corp. k902454 08/30/1990
cedia digoxin plus assay Microgenics Corp. k934168 12/29/1993
cera-chek 1070 blood glucose monitoring system Ceragem Medisys, Inc. k131727 02/28/2014
ceramic alloy no. dw 179 Williams Gold Refining Co., Inc. k852895 10/21/1985
ceryx pacemaker models 114, 314 & 614 Vitatron Medical BV k854790 08/28/1986

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