The following data is part of a premarket notification filed by Ampcare, Llc with the FDA for Reusable Cutaneous Electrode.
| Device ID | K121483 |
| 510k Number | K121483 |
| Device Name: | REUSABLE CUTANEOUS ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | AMPCARE, LLC 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford AMPCARE, LLC 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-18 |
| Decision Date | 2012-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10867786000214 | K121483 | 000 |
| 00867786000200 | K121483 | 000 |