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-single Unit, Lina Operascope With Hdmi Cable And On-board Lcd-6 Units, Lina Operascope Recording Module.
| Device ID | K171113 |
| 510k Number | K171113 |
| Device Name: | 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 |
| Classification | Hysteroscope (and Accessories) |
| Applicant | LiNA Medical ApS Formervangen 5 Glostrup, DK 2600 |
| Contact | Natalia Szychulska |
| Correspondent | Jennifer Tribbett Emergo Global Consulting, LLC 2500 Bee Cave Rd. Bldg. 1, Suite 300 Austin, TX 78746 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-14 |
| Decision Date | 2018-01-04 |
| Summary: | summary |