Fisher & Paykel Electronics, Ltd.
Auckland, New Zealand, NZ
Fisher & Paykel Electronics , Ltd. appears in FDA device records in Auckland, New Zealand, NZ. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Fisher & Paykel Electronics, Ltd. between 1988 and 1998. The busiest year on record is 1997, with 4. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 2 |
| 1992 | 3 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 4 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973161 | CPAP HUMIDIFIER (HC 200) | BZD | Substantially Equivalent | |
| K972885 | SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 | FMT | Substantially Equivalent | |
| K971695 | SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER | FMT | Substantially Equivalent | |
| K971461 | SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) | FMT | Substantially Equivalent | |
| K970432 | INFANT RADIANT WARMER - MODELS IW910 AND IW920 | FMT | Substantially Equivalent | |
| K953392 | HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES) | BTT | Substantially Equivalent | |
| K953711 | AIR ENTRAINER 900RT008 | BZR | Substantially Equivalent | |
| K953949 | HUMIDIFIER & ACCESSORIES | CAW | Substantially Equivalent | |
| K934140 | MR290 HUMIDIFICATION CHAMBER SINGLE USE | BTT | Substantially Equivalent | |
| K924234 | CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272 | KOI | Substantially Equivalent | |
| K915460 | HEATED RESPIRATORY HUMIDIFIER HC100 | BTT | Substantially Equivalent | |
| K913367 | MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS | BTT | Substantially Equivalent | |
| K902386 | MODEL TM101 TEMPERATURE MONITOR | FLL | Substantially Equivalent | |
| K913368 | MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC | BTT | Substantially Equivalent | |
| K892817 | HEATED RESPIRATORY HUMIDIFIER | BTT | Substantially Equivalent | |
| K892885 | RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR | BTL | Substantially Equivalent | |
| K883868 | MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM | BXN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FLLContinuous Measurement Thermometer
- CAWGenerator, Oxygen, Portable
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- BXNStimulator, Nerve, Battery-Powered
- KOIStimulator, Nerve, Peripheral, Electric
- BTLVentilator, Emergency, Powered (Resuscitator)
- BZDVentilator, Non-Continuous (Respirator)
- FMTWarmer, Infant Radiant
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain