The following data is part of a premarket notification filed by Life-tech Instruments, Inc. with the FDA for Electric Response Audiometer.
| Device ID | K780540 |
| 510k Number | K780540 |
| Device Name: | ELECTRIC RESPONSE AUDIOMETER |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | LIFE-TECH INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-03 |
| Decision Date | 1978-04-21 |