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PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181292
510(k) Type
Traditional
Applicant
Cogentix Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/15/2018
Days to Decision
183 days
Submission Type
Summary

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181292
510(k) Type
Traditional
Applicant
Cogentix Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/15/2018
Days to Decision
183 days
Submission Type
Summary