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Azurion R2.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181830
510(k) Type
Special
Applicant
Philips Medical Systems Nederland BV
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
8/2/2018
Days to Decision
24 days
Submission Type
Summary

Azurion R2.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181830
510(k) Type
Special
Applicant
Philips Medical Systems Nederland BV
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
8/2/2018
Days to Decision
24 days
Submission Type
Summary