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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 12 Results
ProductCode: CBK Applicant: RESPIRONICS, INC. Decision Date To: 04/16/2024
 
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ventilator, non-continuous (respirator) Respironics, Inc. K201439 09/25/2020
af541 se full face mask Respironics, Inc. K150638 09/18/2015
performax pediatric se total face mask RESPIRONICS, INC. K120639 07/10/2012
trilogy series ventilator with oximetry RESPIRONICS, INC. K111610 10/14/2011
esprit ventilator with af531 se full face mask RESPIRONICS, INC. K101129 09/16/2010
trilogy 202 ventilator RESPIRONICS, INC. K093905 05/12/2010
trilogy 200 ventilator RESPIRONICS, INC. K093416 01/29/2010
esprit ventilator, model v1000 RESPIRONICS, INC. K034040 01/21/2004
image3 se disposable full face mask RESPIRONICS, INC. K023135 01/03/2003
espirt RESPIRONICS, INC. K001208 05/12/2000
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