The following data is part of a premarket notification filed by Meridian Co., Ltd. with the FDA for Abr-2000.
Device ID | K020360 |
510k Number | K020360 |
Device Name: | ABR-2000 |
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 | 2002-02-04 |
Decision Date | 2002-08-29 |
Summary: | summary |