The following data is part of a premarket notification filed by Life-tech Instruments, Inc. with the FDA for Ear Electrode-adult & Pediatric.
| Device ID | K780537 |
| 510k Number | K780537 |
| Device Name: | EAR ELECTRODE-ADULT & PEDIATRIC |
| Classification | Electrode, Cutaneous |
| Applicant | LIFE-TECH INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-03 |
| Decision Date | 1978-06-02 |