WiZARD 510 Nasal Mask

Ventilator, Non-continuous (respirator)

Apex Medical Corp.

The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Wizard 510 Nasal Mask.

Pre-market Notification Details

Device IDK193206
510k NumberK193206
Device Name:WiZARD 510 Nasal Mask
ClassificationVentilator, Non-continuous (respirator)
Applicant Apex Medical Corp. No. 9, Min Sheng St. Tu-Cheng. New Taipei City,  TW 23679
ContactChieh Yang
CorrespondentChieh Yang
Apex Medical Corp. No. 9, Min Sheng St. Tu-Cheng. New Taipei City,  TW 23679
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-20
Decision Date2020-10-29

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