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Spirotrac

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201562
510(k) Type
Traditional
Applicant
Vitalograph Ireland Ltd.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
10/14/2020
Days to Decision
126 days
Submission Type
Summary

Spirotrac

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201562
510(k) Type
Traditional
Applicant
Vitalograph Ireland Ltd.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
10/14/2020
Days to Decision
126 days
Submission Type
Summary