HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041

Ventilator, Continuous, Facility Use

FISHER & PAYKEL HEALTHCARE, LTD.

The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Hospital Full Face Mask Non Vented, Model: Rt041.

Pre-market Notification Details

Device IDK083122
510k NumberK083122
Device Name:HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
ClassificationVentilator, Continuous, Facility Use
Applicant FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14348 East Tamaki,  NZ
ContactStephanie Coste
CorrespondentStephanie Coste
FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14348 East Tamaki,  NZ
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-22
Decision Date2009-03-04
Summary:summary

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