Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015928685

FEI Number

3015928685

Entity Name

FISHER & PAYKEL HEALTHCARE S.A.DE C.V.

City/State/Country

Tijuana, Baja California, MX

Establishment Address

Blvd La Encantada #24352 Int. A, Fideicomiso El Florido, Tijuana, Baja California CP 22245, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FISHER & PAYKEL HEALTHCARE NZ LTD (Owner Number: 8040217)

Owner / Operator Contact Address

15 MAURICE PAYKEL PLACE, EAST TAMAKI, AUCKLAND, NZ-NOTA 2013, NZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211560

PMA Number

N/A

All Registered Proprietary Names

DaisyDot Sensor Cover DaisyDot Mini Sensor Cover Optiflow Junior 2 WigglewiNG XS S Optiflow Junior 2 WigglewiNG XXL Optiflow Junior 2 WigglewiNG M L XL Airvo 3 F&P Nova Micro PIllows Mask F&P Nova Micro AirSpiral Heated Breathing Tube Optiflow Patient Interface MR850 Respiratory Humidifier F&P Evora Full Mask myAirvo Optiflow Nasal cannula large Nasal cannula small Nasal cannula medium Optiflow+ nasal cannula Nasal cannula extra large Nasal cannula extra small RT oxygen cannula Optiflow oxygen cannula BC oxygen cannula Infosmart Software package MR850 Resipiratory Humidifier F&P 950 Respiratory Humidifier F&P 950 MR290 Humidification Chamber F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling Optiflow Trace F&P 950 Bubble CPAP Breathing Circuit Kits F&P Evora Nasal Mask Infant Evaqua 2 (RT265/RT266) Airvo Nebulizer Adapter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2009-08-04
QAV	High Flow/High Velocity Humidified Oxygen Delivery Device	Anesthesiology	Class 2	868.5454	2023-02-14
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-08-25
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2018-12-20
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-01-29
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2022-03-20
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-09-10
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2005-08-22
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-01-29
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2023-06-26
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-01-29
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2021-04-20
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2023-10-19
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2020-06-02
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2012-08-09
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2022-01-13

Official Correspondent

Brian Schultz

US Agent Details

Diego Vargas Banuelos Business: FISHER & PAYKEL LIMITED HEALTHCARE Email: Diego.VargasBanuelos@fphcare.com Phone: (949) 4341005

Related Public Records

Same Entity

FISHER & PAYKEL HEALTHCARE NZ LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
3008264065	Fisher & Paykel Healthcare S.A.de C.V.	Tijuana Baja California, MX
2085602	FISHER & PAYKEL HEALTHCARE, INC.	IRVINE, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015928685. Last updated year: 2026. Please use registration number 3015928685 when referencing this establishment in official correspondence.