The following data is part of a premarket notification filed by Gerard Medical Enterprises, Inc. with the FDA for Gerard Medical Electrode Tester.
| Device ID | K813358 |
| 510k Number | K813358 |
| Device Name: | GERARD MEDICAL ELECTRODE TESTER |
| Classification | Tester, Electrode, Surface, Electrocardiographic |
| Applicant | GERARD MEDICAL ENTERPRISES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRC |
| CFR Regulation Number | 870.2370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-30 |
| Decision Date | 1981-12-29 |