LiNA OperaScope With HDMI Cable And On-board LCD - 6 Units, LiNA OperaScope Recording Module

Hysteroscope (and Accessories)

LiNA Medical ApS

The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Lina Operascope With Hdmi Cable And On-board Lcd - 6 Units, Lina Operascope Recording Module.

Pre-market Notification Details

Device IDK193007
510k NumberK193007
Device Name:LiNA OperaScope With HDMI Cable And On-board LCD - 6 Units, LiNA OperaScope Recording Module
ClassificationHysteroscope (and Accessories)
Applicant LiNA Medical ApS Formervangen 5 Glostrup,  DK 2600
ContactJaroslaw Mrówczynski
CorrespondentKevin F Macdonald
MacDonald Consulting 4297 D Street Sacramento,  CA  95819
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyObstetrics/Gynecology
510k Review PanelObstetrics/Gynecology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-28
Decision Date2020-01-17

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