The following data is part of a premarket notification filed by Intromedic Co., Ltd with the FDA for E.g. Scan(tm) Ii Esophagoscope System.
| Device ID | K131131 |
| 510k Number | K131131 |
| Device Name: | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM |
| Classification | Esophagoscope (flexible Or Rigid) |
| Applicant | INTROMEDIC CO., LTD 3550 WILSHIRE BLVD #738 Los Angeles, CA 90010 -2401 |
| Contact | Steve Kwon |
| Correspondent | Steve Kwon INTROMEDIC CO., LTD 3550 WILSHIRE BLVD #738 Los Angeles, CA 90010 -2401 |
| Product Code | EOX |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-22 |
| Decision Date | 2013-06-21 |
| Summary: | summary |