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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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Applicant
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510(K)
Number
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Decision
Date
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lapex 2000 MERIDIAN CO., LTD. k034009 01/21/2005
12-lead glove INEEDMD k033559 12/22/2004
sds-4i SKYLARK DEVICE & SYSTEMS CO., LTD k034005 11/18/2004
karats multipurpose solution CIBA VISION CORPORATION k031753 10/28/2004
clarissa infant ncpap cannula AIRWAYS LTD., INC. k032922 09/22/2004
narcotrend, model compact 4.0 MT MONITORTECHNIK GMBH & CO. KG k033543 09/17/2004
carriazo pendular SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG k032910 08/30/2004
tosca pco2, spo2 and pulse rate monitoring system LINDE MEDICAL SENSORS AG k032291 08/24/2004
propper vapor line pcd (steam sterilization process challenge test) PROPPER MFG. CO., INC. k031152 08/17/2004
stimulen collagen SOUTHWEST TECHNOLOGIES, INC. k030774 08/09/2004

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