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WiZARD 310/320 Series CPAP Mask

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182394
510(k) Type
Traditional
Applicant
Apex Medical Corp.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
5/17/2019
Days to Decision
255 days
Submission Type
Summary

WiZARD 310/320 Series CPAP Mask

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182394
510(k) Type
Traditional
Applicant
Apex Medical Corp.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
5/17/2019
Days to Decision
255 days
Submission Type
Summary