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Combined Aerobika OPEP and VersaPAP device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183108
510(k) Type
Traditional
Applicant
Trudell Medical International
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
8/16/2019
Days to Decision
281 days
Submission Type
Summary

Combined Aerobika OPEP and VersaPAP device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183108
510(k) Type
Traditional
Applicant
Trudell Medical International
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
8/16/2019
Days to Decision
281 days
Submission Type
Summary