Fisher &Paykel Healthcare , Ltd. - FDA 510(k) Cleared Devices
70
Total
70
Cleared
0
Denied
70 devices
Cleared
Jan 12, 2005
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
Anesthesiology
380d
Cleared
Aug 31, 2004
HC604 CPAP HUMIDIFIER
Anesthesiology
48d
Cleared
Jun 10, 2004
CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
Anesthesiology
59d
Cleared
May 05, 2004
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
Anesthesiology
68d
Cleared
Apr 13, 2004
MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
Anesthesiology
139d
Cleared
Mar 04, 2004
PRESSURE MANIFOLD, MODEL BC 110
Anesthesiology
20d
Cleared
Jan 14, 2004
ORACLE ORAL MASK, MODEL HC451A
Anesthesiology
107d
Cleared
Jul 07, 2003
RESPIRATORY HUMIDIFIER, MODEL MR850
Anesthesiology
522d
Cleared
Jun 12, 2003
FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
Anesthesiology
232d
Cleared
Jun 12, 2003
SINGLE USE ORAL MASK, MODEL HC455A
Anesthesiology
224d
Cleared
Mar 06, 2003
SURGICAL PATIENT WARMER, MODEL PW820 JHU
Physical Medicine
212d
Cleared
Oct 04, 2001
END EXPIRATORY FILTER, MODEL RT020
General Hospital
387d
Cleared
Jun 25, 2001
ORACLE ORAL MASK
Anesthesiology
189d
Cleared
Jun 01, 2001
RESPIRATORY HUMIDIFIER, MODEL HC150
Anesthesiology
161d
Cleared
Sep 25, 2000
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
General Hospital
49d
Cleared
Nov 10, 1998
RESPIRATORY HUMIDIFIER, MODEL # MR850
Anesthesiology
67d
Cleared
Oct 26, 1998
PATIENT WARMER- MODEL PW810
Physical Medicine
89d
Cleared
May 23, 1996
CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION)
Anesthesiology
359d
Cleared
Mar 09, 1989
MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
Anesthesiology
302d
Cleared
Jul 18, 1988
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
Anesthesiology
34d