The following data is part of a premarket notification filed by Intromedic Co., Ltd with the FDA for E.g. Scan (tm) Esophagoscope System.
| Device ID | K111030 |
| 510k Number | K111030 |
| Device Name: | E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM |
| Classification | Esophagoscope (flexible Or Rigid) |
| Applicant | INTROMEDIC CO., LTD SUITE 1104 E&C VENTURE DREAM TOWER 6-CHA, 197-28 GURO-DONG Guro-gu , Seoul, KR 152719 |
| Contact | Jinyoung Lee |
| Product Code | EOX |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-04-13 |
| Decision Date | 2011-10-21 |
| Summary: | summary |