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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 10 Results
ProductCode: CBK Applicant: RESPIRONICS, INC Decision Date To: 08/27/2015
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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 fac 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
esprit ventilator respironics, inc. K981072 11/12/1998
hayek oscillator, modification respironics, inc. K921726 04/23/1992