END EXPIRATORY FILTER, MODEL RT020

Filter, Bacterial, Breathing-circuit

FISHER & PAYKEL HEALTHCARE, LTD.

The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for End Expiratory Filter, Model Rt020.

Pre-market Notification Details

Device IDK002839
510k NumberK002839
Device Name:END EXPIRATORY FILTER, MODEL RT020
ClassificationFilter, Bacterial, Breathing-circuit
Applicant FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki,  NZ
ContactChris Mander
CorrespondentChris Mander
FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki,  NZ
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-12
Decision Date2001-10-04

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