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O2Vent Optima

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190236
510(k) Type
Traditional
Applicant
Oventus Manufacturing PTY LTD
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
8/29/2019
Days to Decision
204 days
Submission Type
Summary

O2Vent Optima

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190236
510(k) Type
Traditional
Applicant
Oventus Manufacturing PTY LTD
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
8/29/2019
Days to Decision
204 days
Submission Type
Summary