WiZARD 310/320 Series CPAP 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 310/320 Series Cpap Mask.

Pre-market Notification Details

Device IDK182394
510k NumberK182394
Device Name:WiZARD 310/320 Series CPAP Mask
ClassificationVentilator, Non-continuous (respirator)
Applicant Apex Medical Corp. No. 9 Min Sheng St. Tu-Cheng New Taipei City,  TW 23679
ContactFrank Lin
CorrespondentFrank Lin
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 Received2018-09-04
Decision Date2019-05-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14713025000810 K182394 000
14713025000803 K182394 000
14713025000797 K182394 000
14713025000780 K182394 000
14713025000773 K182394 000
04713025000769 K182394 000

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