The following data is part of a premarket notification filed by Applied Medical Research with the FDA for Electrode, Needle, Cfm.
| Device ID | K781311 |
| 510k Number | K781311 |
| Device Name: | ELECTRODE, NEEDLE, CFM |
| Classification | Electrode, Needle |
| Applicant | APPLIED MEDICAL RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-31 |
| Decision Date | 1978-08-21 |