The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Biophysical Monitoring System.
| Device ID | K780425 |
| 510k Number | K780425 |
| Device Name: | BIOPHYSICAL MONITORING SYSTEM |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | GOULD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-17 |
| Decision Date | 1978-04-28 |