The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Reusable Stimulating Electrodes.
| Device ID | K111270 |
| 510k Number | K111270 |
| Device Name: | REUSABLE STIMULATING ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | BIO PROTECH, INC. 3010 LBJ FRWY. 12TH FLOOR Dallas, TX 75234 |
| Contact | Judy Burton |
| Correspondent | Judy Burton BIO PROTECH, INC. 3010 LBJ FRWY. 12TH FLOOR Dallas, TX 75234 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-03 |
| Decision Date | 2011-09-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20612479265596 | K111270 | 000 |
| 20612479265558 | K111270 | 000 |