The following data is part of a premarket notification filed by Dymedix, Inc. with the FDA for Chin Electrode.
| Device ID | K020468 |
| 510k Number | K020468 |
| Device Name: | CHIN ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | DYMEDIX, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring DYMEDIX, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-12 |
| Decision Date | 2002-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817377021418 | K020468 | 000 |
| 10817377022835 | K020468 | 000 |
| 10817377023108 | K020468 | 000 |
| 10817377023115 | K020468 | 000 |
| 10817377021364 | K020468 | 000 |
| 10817377021371 | K020468 | 000 |
| 10817377021388 | K020468 | 000 |
| 10817377021395 | K020468 | 000 |
| 10817377021401 | K020468 | 000 |
| 10817377022828 | K020468 | 000 |