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Oxygen Concentrator, Model JAY-5AW

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213210
510(k) Type
Traditional
Applicant
LONGFIAN SCITECH CO., LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
12/8/2022
Days to Decision
435 days
Submission Type
Summary

Oxygen Concentrator, Model JAY-5AW

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213210
510(k) Type
Traditional
Applicant
LONGFIAN SCITECH CO., LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
12/8/2022
Days to Decision
435 days
Submission Type
Summary