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Skynector CPAP Mask

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150685
510(k) Type
Traditional
Applicant
SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
8/24/2015
Days to Decision
160 days
Submission Type
Summary

Skynector CPAP Mask

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150685
510(k) Type
Traditional
Applicant
SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
8/24/2015
Days to Decision
160 days
Submission Type
Summary