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Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213825
510(k) Type
Traditional
Applicant
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/28/2023
Days to Decision
506 days
Submission Type
Summary

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213825
510(k) Type
Traditional
Applicant
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/28/2023
Days to Decision
506 days
Submission Type
Summary