The following data is part of a premarket notification filed by Princeton Applied Research Corp. with the FDA for Preamplifier Model 113.
| Device ID | K781289 |
| 510k Number | K781289 |
| Device Name: | PREAMPLIFIER MODEL 113 |
| Classification | Amplifier, Physiological Signal |
| Applicant | PRINCETON APPLIED RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-27 |
| Decision Date | 1978-09-14 |