Medical Device Manufacturer · US , Monroeville , PA

Respironics, Inc. - FDA 510(k) Cleared Devices

172 submissions · 168 cleared · Since 1977
172
Total
168
Cleared
0
Denied
154 devices
26-50 of 154
Cleared Dec 31, 2012
RESPIRONICS SIMPLYCLEAR DEVICE
K122111 · SDT
Anesthesiology · 167d
Cleared Dec 14, 2012
BIPAP A 40 VENTILATORY SUPPORT SYSTEM
K121623 · MNT
Anesthesiology · 196d
Cleared Dec 14, 2012
COUGHASSIST T70 DEVICE
K121955 · NHJ
Anesthesiology · 164d
Cleared Oct 09, 2012
REMSTAR SE
K122769 · BZD
Anesthesiology · 29d
Cleared Oct 05, 2012
SIMPLE T NASAL MASK
K121631 · BZD
Anesthesiology · 123d
Cleared Jul 17, 2012
PERFORMAX PEDIATRIC EE TOTAL FACE MASK
K120562 · BZD
Anesthesiology · 144d
Cleared Jul 10, 2012
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
K120639 · CBK
Anesthesiology · 130d
Cleared Mar 30, 2012
SIMPLE T NASAL MASK
K120145 · BZD
Anesthesiology · 72d
Cleared Feb 01, 2012
BIPAP A 30 VENTILATORY SUPPORT SYSTEM
K113053 · MNS
Anesthesiology · 111d
Cleared Dec 16, 2011
REMSTAR AUTO A-FLEX HT
K113068 · BZD
Anesthesiology · 60d
Cleared Nov 04, 2011
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
K111885 · CAW
Anesthesiology · 126d
Cleared Oct 14, 2011
TRILOGY SERIES VENTILATOR WITH OXIMETRY
K111610 · CBK
Anesthesiology · 127d
Cleared Jun 06, 2011
TRUBLUE NASAL MASK
K110405 · BZD
Anesthesiology · 112d
Cleared Jun 01, 2011
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
K110398 · BZE
Anesthesiology · 110d
Cleared Apr 05, 2011
V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
K102985 · MNT
Anesthesiology · 180d
Cleared Mar 24, 2011
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
K102465 · MNS
Anesthesiology · 209d
Cleared Mar 24, 2011
PERFORMAX TOTAL FACE MASK
K103395 · BZD
Anesthesiology · 125d
Cleared Feb 17, 2011
GOLIFE NASAL MASK
K110008 · BZD
Anesthesiology · 45d
Cleared Dec 22, 2010
GOLIFE NASAL MASK
K102502 · BZD
Anesthesiology · 112d
Cleared Sep 16, 2010
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
K101129 · CBK
Anesthesiology · 147d
Cleared Sep 02, 2010
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
K101130 · MNS
Anesthesiology · 133d
Cleared May 12, 2010
TRILOGY 202 VENTILATOR
K093905 · CBK
Anesthesiology · 141d
Cleared Jan 29, 2010
TRILOGY 200 VENTILATOR
K093416 · CBK
Anesthesiology · 88d
Cleared Jan 22, 2010
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
K092818 · MNS
Anesthesiology · 130d
Cleared Aug 05, 2009
BIPAP SYNCHRONY 2
K092043 · MNS
Anesthesiology · 30d

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