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

Cleared Oct 27, 2003

SMARTMONITOR 2 PROFESSIONAL SERIES (PS)

K032403 · NPF

Anesthesiology · 84d

Cleared Jul 30, 2003

BIPAP HARMONY VENTILATORY SUPPORT SYSTEM

K031656 · MNS

Anesthesiology · 63d

Cleared Jun 24, 2003

MODIFICATION TO REMSTAR AUTO CPAP SYSTEM

K031460 · BZD

Anesthesiology · 47d

Cleared Jan 24, 2003

H2 HEATED HUMIDIFIER

K030090 · BTT

Anesthesiology · 14d

Cleared Jan 03, 2003

IMAGE3 SE DISPOSABLE FULL FACE MASK

K023135 · CBK

Anesthesiology · 105d

Cleared Jun 19, 2002

REMSTAR PRO WITH C-FLEX CPAP SYSTEM

K021861 · BZD

Anesthesiology · 13d

Cleared Mar 20, 2002

BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX

K020777 · MNS

Anesthesiology · 9d

Cleared Feb 28, 2002

RESPIRONICS HEATED HUMIDIFIER

K012633 · BTT

Anesthesiology · 199d

Cleared Jan 29, 2002

REMSTAR AUTO CPAP SYSTEM

K012554 · BZD

Anesthesiology · 174d

Cleared Dec 20, 2001

BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM

K012323 · MNS

Anesthesiology · 150d

Cleared Jun 28, 2001

BIPAP PRO BI-LEVEL SYSTEM

K011714 · BZD

Anesthesiology · 24d

Cleared Mar 29, 2001

REMSTAR PLUS CPAP SYSTEM

K010263 · BZD

Anesthesiology · 59d

Cleared Sep 08, 2000

RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223

K000705 · BZD

Anesthesiology · 190d

Cleared Sep 08, 2000

SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876

K002465 · BZD

Anesthesiology · 28d

Cleared Jun 22, 2000

BIPAP DUET LX BI-LEVEL SYSTEM

K000994 · BZD

Anesthesiology · 86d

Cleared May 12, 2000

ESPIRT

K001208 · CBK

Anesthesiology · 28d

Cleared Mar 20, 2000

BIPAP SYNCHRONY HC

K992530 · MNS

Anesthesiology · 236d

Cleared Nov 10, 1999

RESPIRONICS TOTAL FACE MASK

K992969 · BZD

Anesthesiology · 68d

Cleared Oct 27, 1999

ARIA LX CPAP SYSTEM

K993307 · BZD

Anesthesiology · 23d

Cleared Oct 27, 1999

VIRTUOSO LX SMART CPAP SYSTEM

K993433 · BZD

Anesthesiology · 15d

Cleared Aug 13, 1999

MONARCH II MINI MASK

K992336 · BZD

Anesthesiology · 31d

Cleared May 28, 1999

REUSABLE CONTOUR II NASAL MASK

K991648 · BZD

Anesthesiology · 15d

Cleared May 24, 1999

STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964

K990574 · MNT

Anesthesiology · 90d

Cleared May 19, 1999

BIPAP HARMONY S/T, MODEL 1001445

K984407 · MNS

Anesthesiology · 161d

Cleared Apr 19, 1999

SMARTRECORDER, MODEL 2500

K990199 · MNR

Anesthesiology · 88d