The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Endoscope.
| Device ID | K933106 |
| 510k Number | K933106 |
| Device Name: | ENDOSCOPE |
| Classification | Mini Endoscope, Gastroenterology-urology |
| Applicant | ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Contact | Jill Schweiger |
| Correspondent | Jill Schweiger ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Product Code | ODF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-25 |
| Decision Date | 1993-10-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENDOSCOPE 98127497 not registered Live/Pending |
CHEN, XIAOFENG 2023-08-10 |