Data / Medical devices / Mexico / Fisher & Paykel Healthcare S.a.de C.V.
Fisher & Paykel Healthcare S.a.de C.V.: FDA-registered device maker in Tijuana, Baja California, Mexico, 2 510(k) clearances
Fisher & Paykel Healthcare S.a.de C.V. is registered with the FDA (registration 3015928685) in Tijuana, Baja California, Mexico. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 10, 2021. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3015928685
- Address
- Blvd La Encantada #24352 Int. A Fideicomiso El Florido, Tijuana, Baja California, Mexico, CP 22245
- Owner or operator
- FISHER & PAYKEL HEALTHCARE NZ LTD (8040217)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- August 22, 2005
- Registered through
- 2027
- Brand names listed
- AirSpiral Heated Breathing Tube, Airvo 3, Airvo Nebulizer Adapter, BC oxygen cannula, DaisyDot Mini Sensor Cover, DaisyDot Sensor Cover, F&P 950, F&P 950 Bubble CPAP Breathing Circuit Kits and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | 1 | Contract manufacturer | accessdata.fda.gov |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 2 | Contract manufacturer | accessdata.fda.gov |
| High Flow/High Velocity Humidified Oxygen Delivery Device | QAV | 2 | Contract manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Contract manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer | accessdata.fda.gov |
| Noninvasive Positive Airway Pressure System, Facility Use | SGR | 2 | Contract manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 10, 2021 | K211560 | Airvo Nebulizer Adapter | CAF | Substantially Equivalent | Fisher & Paykel Healthcare Limited | accessdata.fda.gov |
| December 22, 2006 | K063036 | OPUS HC482 DIRECT NASAL MASK | BZD | Substantially Equivalent | Fisher & Paykel Healthcare, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Tape And Bandage, Adhesive
- All makers of Noninvasive Positive Airway Pressure System, Facility Use
- All makers of Cannula, Nasal, Oxygen
- All makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Updated December 10, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.