The following data is part of a premarket notification filed by Meridian Co., Ltd. with the FDA for Meridian-ii And Merdian-plus.
| Device ID | K001347 |
| 510k Number | K001347 |
| Device Name: | MERIDIAN-II AND MERDIAN-PLUS |
| Classification | Device, Galvanic Skin Response Measurement |
| Applicant | MERIDIAN CO., LTD. 9FI SEOIL BLDG 222 JAMSILBON-DONG Songpa-gu, Seoul, KR |
| Contact | Soo-rang Lee |
| Correspondent | Soo-rang Lee MERIDIAN CO., LTD. 9FI SEOIL BLDG 222 JAMSILBON-DONG Songpa-gu, Seoul, KR |
| Product Code | GZO |
| CFR Regulation Number | 882.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-28 |
| Decision Date | 2000-11-03 |