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ICS Impulse

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151504
510(k) Type
Traditional
Applicant
GN OTOMETRICS
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
11/16/2015
Days to Decision
165 days
Submission Type
Summary

ICS Impulse

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151504
510(k) Type
Traditional
Applicant
GN OTOMETRICS
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
11/16/2015
Days to Decision
165 days
Submission Type
Summary