Fisher & Paykel Electronics , Ltd.
Medical device manufacturer in Auckland, NZ.
17510(k) clearances
0PMA approvals
0recalls
Device types
- BTT Humidifier, Respiratory Gas, (Direct… 6
- FMT Warmer, Infant Radiant 4
- BXN Stimulator, Nerve, Battery-Powered 1
- BTL Ventilator, Emergency, Powered (Resuscitator) 1
- FLL Continuous Measurement Thermometer 1
- KOI Stimulator, Nerve, Peripheral, Electric 1
- CAW Generator, Oxygen, Portable 1
- BZR Mixer, Breathing Gases, Anesthesia Inhalation 1
- BZD Ventilator, Non-Continuous (Respirator) 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K973161 | CPAP Humidifier (HC 200)BZD · Traditional | 07/10/1998SE |
| K972885 | Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual Control Wall-Mount…FMT · Traditional | 10/30/1997SE |
| K971695 | Servo-Control Cosycot Infant Warmer, Manual-Control Cosycot Infant WarmerFMT · Traditional | 07/28/1997SE |
| K971461 | Servo-Control Wall-Mount Infant WARMER(IW980)/MANUAL-CONTROL Wall-Mount Infant…FMT · Traditional | 07/16/1997SE |
| K970432 | Infant Radiant Warmer - Models IW910 and IW920FMT · Traditional | 05/07/1997SE |
| K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)BTT · Traditional | 03/12/1996SE |
| K953711 | Air Entrainer 900RT008BZR · Traditional | 11/08/1995SE |
| K953949 | Humidifier & AccessoriesCAW · Traditional | 10/16/1995SE |
| K934140 | MR290 Humidification Chamber Single UseBTT · Traditional | 01/24/1994SE |
| K924234 | Cons. Current Periph. Nerve Loc. NS232,NS262,NS272KOI · Traditional | 05/27/1993SE |
| K915460 | Heated Respiratory Humidifier HC100BTT · Traditional | 01/15/1993SE |
| K913367 | Models MR410 & MR480 Respiratory Humidifier/AccessBTT · Traditional | 06/25/1992SE |
| K902386 | Model TM101 Temperature MonitorFLL · Traditional | 01/28/1992SE |
| K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid AccBTT · Traditional | 01/13/1992SE |
| K892817 | Heated Respiratory HumidifierBTT · Traditional | 12/21/1989SE |
| K892885 | Resubmitted RD1000 Neopuff Infant ResuscitatorBTL · Traditional | 10/06/1989SE |
| K883868 | Model NS242 Constant Current Peripheral Nerve StimBXN · Traditional | 11/28/1988SE |