PRESSURE MANIFOLD, MODEL BC 110

Valve, Non-rebreathing

FISHER & PAYKEL HEALTHCARE, LTD.

The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Pressure Manifold, Model Bc 110.

Pre-market Notification Details

Device IDK040366
510k NumberK040366
Device Name:PRESSURE MANIFOLD, MODEL BC 110
ClassificationValve, Non-rebreathing
Applicant FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki,  NZ
ContactRobert Petry
CorrespondentRobert Petry
FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki,  NZ
Product CodeCBP  
CFR Regulation Number868.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-13
Decision Date2004-03-04
Summary:summary

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