MODEL MR2000 HEATED RESPIRATORY 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 Model Mr2000 Heated Respiratory Humidifier.

Pre-market Notification Details

Device IDK881970
510k NumberK881970
Device Name:MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant FISHER & PAYKEL HEALTHCARE, LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand,  NZ
ContactDavid Milburn
CorrespondentDavid Milburn
FISHER & PAYKEL HEALTHCARE, LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand,  NZ
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-11
Decision Date1989-03-09

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