The following data is part of a premarket notification filed by Daehan Medical Systems Co., Ltd. with the FDA for Daehan Disposable Cup Electrodes.
Device ID | K180232 |
510k Number | K180232 |
Device Name: | DAEHAN Disposable CUP Electrodes |
Classification | Electrode, Cutaneous |
Applicant | Daehan Medical Systems Co., Ltd. 250 Okgucheondong-Ro Siheung-city, KR 15084 |
Contact | Da Roo Ha |
Correspondent | Da Roo Ha Daehan Medical Systems Co., Ltd. 250 Okgucheondong-Ro Siheung-city, KR 15084 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-01-29 |
Decision Date | 2019-04-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08800036901829 | K180232 | 000 |