The following data is part of a premarket notification filed by Life-tech Instruments, Inc. with the FDA for Pressure Modules Models 1855 & 1856.
| Device ID | K780541 |
| 510k Number | K780541 |
| Device Name: | PRESSURE MODULES MODELS 1855 & 1856 |
| Classification | Electromyograph, Diagnostic |
| Applicant | LIFE-TECH INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-03 |
| Decision Date | 1978-05-19 |