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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)
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Decision
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parset secondary administration set, luerlock, model a14001e, parset secondary secondary administration set, model a1400 RD MEDICAL MFG., INC. k000017 02/10/2000
leveen needle electrode RADIOTHERAPEUTICS CORP. k000032 03/30/2000
xplan 2.1 RADIONICS, INC. k001700 06/28/2000
infared ear thermometer, model th8 series RADIANT INNOVATION, INC. k011059 09/17/2001
swabsite swabbable valve, model 245000 QUEST MEDICAL, INC. k002689 03/06/2001
quantase phenylalanine screening assay 500 test kit QUANTASE LTD. k000754 06/19/2000
puritan-bennett 840 ventilator system with neomode option PURITAN BENNETT CORP. k001646 10/20/2000
pst electrosurgical generator, model 2150, pst bipolar forceps, model ebf 1228 PST, INC. k003249 12/12/2000
micropaq, models 402 and 404 PROTOCOL SYSTEMS, INC. k002725 11/21/2000
bone biopsy needle PROMEX, INC. k001132 05/01/2000

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