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 |