ZEST NASAL MASK

Ventilator, Non-continuous (respirator)

FISHER & PAYKEL HEALTHCARE, LTD.

The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Zest Nasal Mask.

Pre-market Notification Details

Device IDK083832
510k NumberK083832
Device Name:ZEST NASAL MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14348 East Tamaki,  NZ
ContactTina Mason
CorrespondentTina Mason
FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14348 East Tamaki,  NZ
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-23
Decision Date2009-03-16
Summary:summary

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