The following data is part of a premarket notification filed by Ag Garments with the FDA for Ag Garments Conductive Electrodes, Models 100-104 Sleeves,110-114 Gloves,120-124 Socks,130-132 Panels.
| Device ID | K023212 |
| 510k Number | K023212 |
| Device Name: | AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS |
| Classification | Electrode, Cutaneous |
| Applicant | AG GARMENTS 1762 COLUMBIA ST. San Diego, CA 92101 |
| Contact | Athena Shudde |
| Correspondent | Athena Shudde AG GARMENTS 1762 COLUMBIA ST. San Diego, CA 92101 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-26 |
| Decision Date | 2002-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857771003583 | K023212 | 000 |
| 00850706007014 | K023212 | 000 |
| 00850706007021 | K023212 | 000 |
| 00857771003392 | K023212 | 000 |
| 00857771003439 | K023212 | 000 |
| 00857771003446 | K023212 | 000 |
| 00857771003453 | K023212 | 000 |
| 00857771003460 | K023212 | 000 |
| 00857771003477 | K023212 | 000 |
| 00857771003484 | K023212 | 000 |
| 00857771003491 | K023212 | 000 |
| 00857771003507 | K023212 | 000 |
| 00857771003514 | K023212 | 000 |
| 00857771003576 | K023212 | 000 |
| 00850706007007 | K023212 | 000 |