HEATED RESPIRATORY HUMIDIFIER HC100

Humidifier, Respiratory Gas, (direct Patient Interface)

FISHER & PAYKEL ELECTRONICS LTD.

The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Heated Respiratory Humidifier Hc100.

Pre-market Notification Details

Device IDK915460
510k NumberK915460
Device Name:HEATED RESPIRATORY HUMIDIFIER HC100
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand,  NZ
ContactRichard Belgrave
CorrespondentRichard Belgrave
FISHER & PAYKEL ELECTRONICS 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 Received1991-12-04
Decision Date1993-01-15

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