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CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K120550
510(k) Type
Traditional
Applicant
BIOSENSE WEBSTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/7/2012
Days to Decision
74 days
Submission Type
Summary

CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K120550
510(k) Type
Traditional
Applicant
BIOSENSE WEBSTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/7/2012
Days to Decision
74 days
Submission Type
Summary