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LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193007
510(k) Type
Traditional
Applicant
LiNA Medical ApS
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
1/17/2020
Days to Decision
81 days
Submission Type
Summary

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193007
510(k) Type
Traditional
Applicant
LiNA Medical ApS
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
1/17/2020
Days to Decision
81 days
Submission Type
Summary