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AUDICOR CA300/CC100 Analyzer with SDB

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151433
510(k) Type
Traditional
Applicant
INOVISE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/18/2016
Days to Decision
295 days
Submission Type
Summary

AUDICOR CA300/CC100 Analyzer with SDB

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151433
510(k) Type
Traditional
Applicant
INOVISE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/18/2016
Days to Decision
295 days
Submission Type
Summary