The following data is part of a premarket notification filed by Life-tech Instruments, Inc. with the FDA for Preamplifier Models 8101pi & 8102pi.
| Device ID | K781474 |
| 510k Number | K781474 |
| Device Name: | PREAMPLIFIER MODELS 8101PI & 8102PI |
| Classification | Audiometer |
| Applicant | LIFE-TECH INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-28 |
| Decision Date | 1978-09-07 |