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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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calciject Centrix, Inc. k001050 07/21/2000
cadhealth system, model chp-001 Caduceus Health Care , Ltd. k002514 05/31/2001
ca 125 ii calcheck Roche Diagnostics Corp. k003967 01/12/2001
c100 qt variable height adjustment incubator Air-Shields Vickers, Inc. k884086 11/14/1988
c-it Bregas AB k000520 05/16/2000
brentwood iqmark digital spirometer (includes disposable pneumotach mouthpieces and 3-liter calibration syringe Brentwood Medical Technology Corp. k002499 11/08/2000
breathing filter for disposable anesthesia breathing circuit Sims Portex, Inc. k002506 12/14/2000
blood urea nitrogen Catachem, Inc. k874532 01/05/1988
blood pressure monitor Guangdong Transtek Medical Electronics Co., Ltd. k232713 11/28/2023
biosign flu a + b, status flu a & b Princeton BioMeditech Corp. k133474 12/10/2013

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