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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
Date
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cpap system, model 102001 SIMS PORTEX, INC. k001318 07/20/2000
creatinine-s assay, model 221-30, 221-50, 221-17 DIAGNOSTIC CHEMICALS LTD. k000055 02/18/2000
cs/3 critical care monitor with s-icu99(a) DATEX-OHMEDA k000168 04/13/2000
d. r. medical controlled pressure garments CONFECTION MEDICALE D.R., INC. k001300 08/30/2000
danmar products michigan cranial helmet DANMAR PRODUCTS, INC. k003630 05/29/2001
datascope profile 8fr. alt b iab, 34cc, datascope profile 8fr. alt b iab, 40cc, model 0684-000319, 0684-00-0320 DATASCOPE CORP. k003598 12/21/2000
datex-ohmeda aestiva/5 with 7100 ventilator DATEX-OHMEDA, INC. k000706 05/11/2000
datex-ohmeda inovent delivery system DATEX-OHMEDA k000186 02/10/2000
datex-ohmeda tuffsat 3000 pulse oximeter DATEX-OHMEDA, INC. k001688 06/30/2000
delta 32 and delta 32 tact INSTRUMENTARIUM IMAGING, INC. k002472 11/29/2000

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