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 |