The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Corometrics-push Button Spiral Electrode.
| Device ID | K792669 |
| 510k Number | K792669 |
| Device Name: | COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE |
| Classification | Electrode, Circular (spiral), Scalp And Applicator |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGP |
| CFR Regulation Number | 884.2675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-27 |
| Decision Date | 1980-02-11 |