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Accuryn Monitoring System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153655
510(k) Type
Traditional
Applicant
POTRERO MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
4/15/2016
Days to Decision
116 days
Submission Type
Summary

Accuryn Monitoring System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153655
510(k) Type
Traditional
Applicant
POTRERO MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
4/15/2016
Days to Decision
116 days
Submission Type
Summary