The following data is part of a premarket notification filed by Medrobotics Corporation with the FDA for Medrobotics Flex Robotic System.
Device ID | K172036 |
510k Number | K172036 |
Device Name: | Medrobotics Flex Robotic System |
Classification | Colonoscope And Accessories, Flexible/rigid |
Applicant | Medrobotics Corporation 475 Paramount Drive Raynham, MA 02767 |
Contact | John D. Bonasera |
Correspondent | John D. Bonasera Medrobotics Corporation 475 Paramount Drive Raynham, MA 02767 |
Product Code | FDF |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-05 |
Decision Date | 2017-08-03 |
Summary: | summary |