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
126-150 of 154
Cleared Jul 21, 1993
HAYEK OSCILLATOR(TM)
K924341 · BYT
Anesthesiology · 328d
Cleared Jul 21, 1993
TOTAL FACE MASK
K925920 · BZD
Anesthesiology · 240d
Cleared Dec 07, 1992
REMSTAR WTIH RAMP AND REMOTE MODIFICATION
K920699 · BZD
Anesthesiology · 313d
Cleared Apr 23, 1992
HAYEK OSCILLATOR, MODIFICATION
K921726 · CBK
Anesthesiology · 15d
Cleared Aug 09, 1991
RESPIRONICS REMSTAR WITH REMOTE AND RAMP
K911856 · BZD
Anesthesiology · 105d
Cleared Apr 03, 1991
RESPIRONICS' DIGITAL MANOMETER
K904935 · CAP
Anesthesiology · 153d
Cleared Jan 30, 1991
RESPIRONICS BIPAP REMOTE CONTROL UNIT
K905540 · BZD
Anesthesiology · 50d
Cleared Aug 17, 1990
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276 · CAP
Anesthesiology · 88d
Cleared Mar 28, 1990
RESPIRONICS' REMSTAR(TM) SLEEPEASY
K900113 · BYE
Anesthesiology · 78d
Cleared Dec 22, 1989
RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM
K895849 · BYT
Anesthesiology · 80d
Cleared Oct 27, 1989
RESPIRONICS INFANT BAGEASY
K895351 · BTM
Anesthesiology · 56d
Cleared Apr 20, 1989
RESPIRONICS SEALEASY II
K890795 · BSJ
Anesthesiology · 62d
Cleared Dec 08, 1988
MODIFIED SANDERS BI-PAPEASY
K883825 · BYE
Anesthesiology · 90d
Cleared Aug 19, 1988
RESPIRONIC'S INFANT SECUREEASY
K882079 · CBH
Anesthesiology · 94d
Cleared Jul 14, 1988
RESPIRONICS SUCTIONEASY
K882017 · BSY
Anesthesiology · 62d
Cleared Jul 16, 1987
RESPIRONICS SANDERS BIPAPEASY
K871523 · BYE
Anesthesiology · 87d
Cleared Nov 04, 1986
RESPIRONICS PTL REVIVEEASY
K863172 · CAO
Anesthesiology · 78d
Cleared Oct 15, 1986
RESPIRONICS PROTECTEASY
K863171 · KGK
Anesthesiology · 58d
Cleared Mar 13, 1986
RESPIRONICS SECUREASY
K860845 · CBH
Anesthesiology · 7d
Cleared May 15, 1985
SANDER'S MASKCPAP BY RESPIRONICS
K851396 · BYE
Anesthesiology · 36d
Cleared Dec 04, 1984
RESPIRONICS SLEEPEASY NASAL CPAP SYS
K843889 · BYE
Anesthesiology · 63d
Cleared Aug 10, 1984
RESPIRONICS VENTEASY
K842693 · BTM
Anesthesiology · 30d
Cleared Jul 27, 1984
RESPIRONICS VENT EASY OXYGEN ENRICHME
K842605 · CAE
Anesthesiology · 22d
Cleared Dec 16, 1983
RESPIRONICS RESCUE DOME
K833328 · CAE
Anesthesiology · 80d
Cleared Dec 08, 1983
RESCUE VALVE
K833748 · CBP
Anesthesiology · 43d

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