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U.S. Department of Health and Human Services

510(K) Premarket Notification

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51 to 60 of 500 Results *
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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pc flow + SPIROMETRICS MEDICAL EQUIPMENT CO. k001528 01/18/2001
cosmed quark COSMED S.R.L. k001174 01/11/2001
dried gram-positive mic/combo panels DADE MICROSCAN, INC. k003619 01/09/2001
kenz ecg 108 single channel digital electrocardiographs; kenz ecg 110 single channel digital electrocardiographs with ec SUZUKEN CO., LTD. k001896 01/08/2001
zynergy balloonpace balloon guided pacing and monitoring catheter ZCV ,INC. k002603 01/08/2001
aktina medical physics corporation active breathing coordinator (abc) AKTINA MEDICAL PHYSICS CORP. k003330 01/04/2001
orion platinum SRS MEDICAL SYSTEMS, INC. k003367 01/04/2001
eva -vacuum assist device for clitoral therapy PROSURG, INC. k001576 12/28/2000
apnoescreen pro, alpha screen pro ERICH JAEGER, INC. k000396 12/27/2000
immulite high sensitivity crp, immulite 2000 high sensitivity crp DIAGNOSTIC PRODUCTS CORP. k003372 12/26/2000

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