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Q13 SPIROLYSER®

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161676
510(k) Type
Traditional
Applicant
FIM MEDICAL
Country
France
FDA Decision
Substantially Equivalent
Decision Date
10/20/2016
Days to Decision
125 days
Submission Type
Summary

Q13 SPIROLYSER®

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161676
510(k) Type
Traditional
Applicant
FIM MEDICAL
Country
France
FDA Decision
Substantially Equivalent
Decision Date
10/20/2016
Days to Decision
125 days
Submission Type
Summary