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Model 9100 PFT/DICO

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221030
510(k) Type
Traditional
Applicant
Vitalograph Ireland Ltd.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
7/15/2022
Days to Decision
99 days
Submission Type
Summary

Model 9100 PFT/DICO

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221030
510(k) Type
Traditional
Applicant
Vitalograph Ireland Ltd.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
7/15/2022
Days to Decision
99 days
Submission Type
Summary