510(k) K171113
LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module by
Lina Medical Aps
— Product Code HIH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2018
- Date Received
- April 14, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hysteroscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type