AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER

Humidifier, Respiratory Gas, (direct Patient Interface)

FISHER & PAYKEL HEALTHCARE, LTD.

The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Airvo 2 Humidifier, Myairvo 2 Humidifier.

Pre-market Notification Details

Device IDK131895
510k NumberK131895
Device Name:AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki,  NZ 2013
ContactBrett Whiston
CorrespondentBrett Whiston
FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki,  NZ 2013
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-25
Decision Date2013-10-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09420012427830 K131895 000
09420012427793 K131895 000
09420012427816 K131895 000
09420012427823 K131895 000
09420012427786 K131895 000
09420012422859 K131895 000
09420012422347 K131895 000
09420012422248 K131895 000
09420012467577 K131895 000

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