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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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fetalgard lite ANALOGIC CORP. k002503 11/09/2000
brentwood iqmark digital spirometer (includes disposable pneumotach mouthpieces and 3-liter calibration syringe BRENTWOOD MEDICAL TECHNOLOGY CORP. k002499 11/08/2000
ceram-prime S & C POLYMER GMBH k002502 11/08/2000
km-10 tens electrode KATECHO, INC. k000870 11/07/2000
qualitrol dhp immunoassay control, levels 1,2, and 3 CONSOLIDATED TECHNOLOGIES OF WISCONSIN k001249 11/02/2000
omnipulse holmium laser system, omnipulse-max holmium laser system, model 1210, 1210-vhp, 1500-a TRIMEDYNE, INC. k001676 11/02/2000
power 5000 general purpose coil USA INSTRUMENTS, INC. k002483 10/25/2000
simplicity soft infusion set STERLING MEDIVATIONS, INC. k002492 10/24/2000
x-posure system version 2 rad PRONOSCO A/S k002500 10/23/2000
puritan-bennett 840 ventilator system with neomode option PURITAN BENNETT CORP. k001646 10/20/2000

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