The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Protens Electrode.
| Device ID | K042301 |
| 510k Number | K042301 |
| Device Name: | PROTENS ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | BIO PROTECH, INC. 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 |
| Contact | E.j. Edward |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-08-25 |
| Decision Date | 2004-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M220P6409555 | K042301 | 000 |
| M220P5408513 | K042301 | 000 |
| M220P6408523 | K042301 | 000 |
| M220P640853 | K042301 | 000 |
| M220P6408543 | K042301 | 000 |
| M220P6408533 | K042301 | 000 |
| M220P6409513 | K042301 | 000 |
| M220P6409523 | K042301 | 000 |
| M220P6409533 | K042301 | 000 |
| M220P6409543 | K042301 | 000 |
| 00850706007304 | K042301 | 000 |