The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Vizishot 2 Flex.
Device ID | K163469 |
510k Number | K163469 |
Device Name: | ViziShot 2 FLEX |
Classification | Bronchoscope Accessory |
Applicant | Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 -2104 |
Contact | Mary Anne Patella |
Correspondent | Mary Anne Patella Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 -2104 |
Product Code | KTI |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-12 |
Decision Date | 2017-04-06 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VIZISHOT 2 FLEX 97768646 not registered Live/Pending |
OLYMPUS CORPORATION 2023-01-26 |