The following data is part of a premarket notification filed by Zimmer Elektromedizin Gmbh with the FDA for Disposable Therapy Electrode.
| Device ID | K924473 |
| 510k Number | K924473 |
| Device Name: | DISPOSABLE THERAPY ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | ZIMMER ELEKTROMEDIZIN GMBH 25 MAUCHLY, SUITE 300 Irvine, CA 92718 |
| Contact | Dal Molin |
| Correspondent | Dal Molin ZIMMER ELEKTROMEDIZIN GMBH 25 MAUCHLY, SUITE 300 Irvine, CA 92718 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-31 |
| Decision Date | 1993-05-19 |