Medical Device Manufacturer · NZ , Auckland, New Zealand

Fisher & Paykel Electronics , Ltd. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 1988

17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fisher & Paykel Electronics , Ltd. Anesthesiology ✕

12 devices

1-12 of 12

Cleared Jul 10, 1998

CPAP HUMIDIFIER (HC 200)

Anesthesiology · 322d

Cleared Mar 12, 1996

HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)

Anesthesiology · 237d

Cleared Nov 08, 1995

AIR ENTRAINER 900RT008

Anesthesiology · 91d

Cleared Oct 16, 1995

HUMIDIFIER & ACCESSORIES

Anesthesiology · 55d

Cleared Jan 24, 1994

MR290 HUMIDIFICATION CHAMBER SINGLE USE

Anesthesiology · 152d

Cleared May 27, 1993

CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272

Anesthesiology · 276d

Cleared Jan 15, 1993

HEATED RESPIRATORY HUMIDIFIER HC100

Anesthesiology · 408d

Cleared Jun 25, 1992

MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS

Anesthesiology · 337d

Cleared Jan 13, 1992

MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC

Anesthesiology · 173d

Cleared Dec 21, 1989

HEATED RESPIRATORY HUMIDIFIER

Anesthesiology · 248d

Cleared Oct 06, 1989

RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR

Anesthesiology · 170d

Cleared Nov 28, 1988

MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM

Anesthesiology · 76d