The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Telectrode Wet Gel Ecg Electrode.
| Device ID | K083148 |
| 510k Number | K083148 |
| Device Name: | TELECTRODE WET GEL ECG ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | BIO PROTECH, INC. 1720-26 TAEJANG 2-DONG, WONJU Woonju-si, Gangwon-do, KR |
| Contact | Kevin Han |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-10-24 |
| Decision Date | 2008-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817325022415 | K083148 | 000 |
| 20817325022303 | K083148 | 000 |
| 20817325022310 | K083148 | 000 |
| 20817325022327 | K083148 | 000 |
| 20817325022334 | K083148 | 000 |
| 20817325022341 | K083148 | 000 |
| 20817325022358 | K083148 | 000 |
| 20817325022365 | K083148 | 000 |
| 20817325022372 | K083148 | 000 |
| 20817325022389 | K083148 | 000 |
| 20817325022396 | K083148 | 000 |
| 00817325022408 | K083148 | 000 |
| 28809083947747 | K083148 | 000 |