The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Endoscope.
| Device ID | K921883 |
| 510k Number | K921883 |
| Device Name: | ENDOSCOPE |
| Classification | Endoscope, Rigid |
| Applicant | OPTIMED TECHNOLOGIES, INC. 2440 N. GLASSELL ST. SUITE J Orange, CA 92665 |
| Contact | Ronald J Ehmsen |
| Correspondent | Ronald J Ehmsen OPTIMED TECHNOLOGIES, INC. 2440 N. GLASSELL ST. SUITE J Orange, CA 92665 |
| Product Code | GCM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-21 |
| Decision Date | 1992-11-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENDOSCOPE 98127497 not registered Live/Pending |
CHEN, XIAOFENG 2023-08-10 |