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HEARTNAVIGATOR RELEASE 2.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140138
510(k) Type
Abbreviated
Applicant
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/2014
Days to Decision
139 days
Submission Type
Summary

HEARTNAVIGATOR RELEASE 2.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140138
510(k) Type
Abbreviated
Applicant
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/2014
Days to Decision
139 days
Submission Type
Summary