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Pressio 2 ICP Monitoring System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162108
510(k) Type
Traditional
Applicant
SOPHYSA, SA
Country
France
FDA Decision
Substantially Equivalent
Decision Date
4/17/2017
Days to Decision
262 days
Submission Type
Summary

Pressio 2 ICP Monitoring System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162108
510(k) Type
Traditional
Applicant
SOPHYSA, SA
Country
France
FDA Decision
Substantially Equivalent
Decision Date
4/17/2017
Days to Decision
262 days
Submission Type
Summary