The following data is part of a premarket notification filed by Dongjin Medical Co., Ltd with the FDA for I-scope 200.
| Device ID | K062364 |
| 510k Number | K062364 |
| Device Name: | I-SCOPE 200 |
| Classification | Stethoscope, Electronic |
| Applicant | DONGJIN MEDICAL CO., LTD #1022 SICOX TOWER, 513-14 SANGDAEWON-DONG, CHUNGWON-KU Sungnam-si, Kyunggi-do, KR 462-806 |
| Contact | Min-kang Kim |
| Correspondent | Min-kang Kim DONGJIN MEDICAL CO., LTD #1022 SICOX TOWER, 513-14 SANGDAEWON-DONG, CHUNGWON-KU Sungnam-si, Kyunggi-do, KR 462-806 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-14 |
| Decision Date | 2006-12-06 |
| Summary: | summary |