The following data is part of a premarket notification filed by Wandy Rubber Industrial Co., Ltd with the FDA for Body Signal Ecg Electrode.
| Device ID | K031174 |
| 510k Number | K031174 |
| Device Name: | BODY SIGNAL ECG ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | WANDY RUBBER INDUSTRIAL CO., LTD NO.24, ALLEY 37, LANE 392 FU TEH 1ST RD. Shi-chih, TW 221 |
| Contact | Janis Yang |
| Correspondent | Janis Yang WANDY RUBBER INDUSTRIAL CO., LTD NO.24, ALLEY 37, LANE 392 FU TEH 1ST RD. Shi-chih, TW 221 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-14 |
| Decision Date | 2003-07-10 |