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U.S. Department of Health and Human Services

510(k) Premarket Notification
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101 to 110 of 167 Results
ProductCode: MNR Decision Date To: 09/26/2021
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maxxi flow sensor Neurovirtual USA, INC. K201495 12/14/2020
matrx plus Zephyr Sleep Technologies K200695 08/24/2020
matrx plus Zephyr Sleep Technologies K163665 05/05/2017
matrx plus Zephyr Sleep Technologies K181996 11/21/2018
matrx plus Zephyr Sleep Technologies K191925 10/29/2019
lifescreen apnea DEL MAR REYNOLDS MEDICAL, INC. K042745 01/19/2005
inomax ds (delivery system) INO THERAPEUTICS LLC K090958 06/18/2009
holter lx analysis NORTH EAST MONITORING INC. K081861 12/04/2008
hc1000p sleep diagnosis software system HYPNOCORE, LTD. K073269 04/18/2008
galaxy RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP K083874 01/26/2009
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