The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Pmt Truscan Surface Electrode.
| Device ID | K122376 |
| 510k Number | K122376 |
| Device Name: | PMT TRUSCAN SURFACE ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | PMT CORP. 1500 PARK RD Chanhassen, MN 55317 |
| Contact | Al Iversen |
| Correspondent | Al Iversen PMT CORP. 1500 PARK RD Chanhassen, MN 55317 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-06 |
| Decision Date | 2012-12-19 |
| Summary: | summary |