The following data is part of a premarket notification filed by Era Endoscopy S.r.l. with the FDA for Endotics.
Device ID | K190669 |
510k Number | K190669 |
Device Name: | Endotics |
Classification | Colonoscope And Accessories, Flexible/rigid |
Applicant | Era Endoscopy S.r.l. Via Boccioni, 1 Peccioli, IT 56037 |
Contact | Alberto Arena |
Correspondent | Alberto Arena Era Endoscopy S.r.l. Via Boccioni, 1 Peccioli, IT 56037 |
Product Code | FDF |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-15 |
Decision Date | 2020-01-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOTICS 88361354 not registered Live/Pending |
Era Endoscopy S.r.l. 2019-03-28 |
ENDOTICS 79110712 4232032 Dead/Cancelled |
Era Endoscopy S.r.l. 2012-01-18 |