Company ยท NZ
Fisher & Paykel Electronics , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1998. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 6 |
| FMT | Warmer, Infant Radiant | 4 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 |
| CAW | Generator, Oxygen, Portable | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 1998 | K973161 | CPAP HUMIDIFIER (HC 200) Fisher & Paykel Electronics , Ltd., NZ | BZD |
| Oct 30, 1997 | K972885 | SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 Fisher & Paykel Electronics , Ltd., NZ | FMT |
| Jul 28, 1997 | K971695 | SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER Fisher & Paykel Electronics , Ltd., NZ | FMT |
| Jul 16, 1997 | K971461 | SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) Fisher & Paykel Electronics , Ltd., NZ | FMT |
| May 7, 1997 | K970432 | INFANT RADIANT WARMER - MODELS IW910 AND IW920 Fisher & Paykel Electronics , Ltd., NZ | FMT |
| Mar 12, 1996 | K953392 | HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES) Fisher & Paykel Electronics , Ltd., NZ | BTT |
| Nov 8, 1995 | K953711 | AIR ENTRAINER 900RT008 Fisher & Paykel Electronics , Ltd., NZ | BZR |
| Oct 16, 1995 | K953949 | HUMIDIFIER & ACCESSORIES Fisher & Paykel Electronics , Ltd., NZ | CAW |
| Jan 24, 1994 | K934140 | MR290 HUMIDIFICATION CHAMBER SINGLE USE Fisher & Paykel Electronics , Ltd., NZ | BTT |
| May 27, 1993 | K924234 | CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272 Fisher & Paykel Electronics , Ltd., NZ | KOI |
| Jan 15, 1993 | K915460 | HEATED RESPIRATORY HUMIDIFIER HC100 Fisher & Paykel Electronics , Ltd., NZ | BTT |
| Jun 25, 1992 | K913367 | MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS Fisher & Paykel Electronics , Ltd., NZ | BTT |
| Jan 28, 1992 | K902386 | MODEL TM101 TEMPERATURE MONITOR Fisher & Paykel Electronics , Ltd., NZ | FLL |
| Jan 13, 1992 | K913368 | MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC Fisher & Paykel Electronics , Ltd., NZ | BTT |
| Dec 21, 1989 | K892817 | HEATED RESPIRATORY HUMIDIFIER Fisher & Paykel Electronics , Ltd., NZ | BTT |
| Oct 6, 1989 | K892885 | RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR Fisher & Paykel Electronics , Ltd., NZ | BTL |
| Nov 28, 1988 | K883868 | MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM Fisher & Paykel Electronics , Ltd., NZ | BXN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||