OPUS HC482 DIRECT 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 Opus Hc482 Direct Nasal Mask.

Pre-market Notification Details

Device IDK063036
510k NumberK063036
Device Name:OPUS HC482 DIRECT NASAL MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, Auckland,  NZ 2013
ContactJayanti Karandikar
CorrespondentJayanti Karandikar
FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, Auckland,  NZ 2013
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-03
Decision Date2006-12-22
Summary:summary

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