Medical Device Manufacturer · NZ , Auckland, New Zealand

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

17 submissions · 17 cleared · Since 1988

Recent clearances: CPAP HUMIDIFIER (HC 200), SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970, SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER

17

Total

17

Cleared

0

Denied

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

5 devices

1-5 of 5

Cleared Oct 30, 1997

SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL...

General Hospital · 86d

Cleared Jul 28, 1997

SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER

General Hospital · 81d

Cleared Jul 16, 1997

SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT...

General Hospital · 86d

Cleared May 07, 1997

INFANT RADIANT WARMER - MODELS IW910 AND IW920

General Hospital · 92d

Cleared Jan 28, 1992

MODEL TM101 TEMPERATURE MONITOR

General Hospital · 608d