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
101-125 of 154
Cleared Nov 12, 1998
ESPRIT VENTILATOR
K981072 · CBK
Anesthesiology · 233d
Cleared Nov 03, 1998
BIPAP VISION VENTILATORY SUPPORT
K982454 · MNT
Anesthesiology · 111d
Cleared Oct 05, 1998
BROWSER (EVENT SOFTWARE) MODEL # 4500E
K982550 · BZQ
Anesthesiology · 75d
Cleared May 14, 1998
STARDUST
K973920 · MNR
Anesthesiology · 211d
Cleared Oct 28, 1997
CRICKET 2000 RECORDING PULSE OXIMETER
K972829 · DQA
Anesthesiology · 90d
Cleared Apr 18, 1997
QUARTET CLINICAL SYSTEM
K963761 · BZD
Anesthesiology · 212d
Cleared Feb 14, 1997
OASIS HUMIDIFIER
K964653 · BTT
Anesthesiology · 86d
Cleared Jan 30, 1997
BIPAP DUET SYSTEM
K964363 · BZD
Anesthesiology · 90d
Cleared Dec 20, 1996
BIPAP S/T-D 30 SYSTEM
K955324 · MNT
Anesthesiology · 396d
Cleared Dec 05, 1996
WHISPER SWIVEL II EXHALATION PORT
K962203 · BZD
Anesthesiology · 181d
Cleared Nov 14, 1996
PRESSURE VALVE
K963250 · BZD
Anesthesiology · 87d
Cleared Sep 30, 1996
VIRTUOSO SMART CPAP SYSTEM
K953930 · BZD
Anesthesiology · 406d
Cleared Aug 15, 1996
SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE
K961915 · BZD
Anesthesiology · 90d
Cleared Jul 29, 1996
BIPAP MODEL S/T-D
K951264 · MNT
Anesthesiology · 496d
Cleared Jul 18, 1996
SOLO CPAP SYSTEM
K961626 · BZD
Anesthesiology · 83d
Cleared Jun 26, 1996
MAESTRO CLINICAL REMOTE CONTROL
K954572 · BZD
Anesthesiology · 268d
Cleared Mar 01, 1996
HUMIDIFIER
K945782 · BTT
Anesthesiology · 462d
Cleared Jan 31, 1996
RESPIRONICS MONARCH MINI MASK
K945938 · BZD
Anesthesiology · 422d
Cleared Jan 31, 1996
GEL MASK
K954207 · BZD
Anesthesiology · 146d
Cleared Jan 30, 1996
ARIA CPAP SYSTEM
K953341 · BZD
Anesthesiology · 266d
Cleared Mar 29, 1995
SPECTRUM(TM) MASK
K936047 · BZD
Anesthesiology · 464d
Cleared Jan 05, 1995
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
K934699 · BTM
Anesthesiology · 462d
Cleared May 06, 1994
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
K940581 · BTM
Anesthesiology · 87d
Cleared Dec 14, 1993
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
K934310 · BTM
Anesthesiology · 104d
Cleared Sep 14, 1993
NASAL/ORAL MASK
K925587 · BZD
Anesthesiology · 313d

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