The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Pm-3.
| Device ID | K831750 |
| 510k Number | K831750 |
| Device Name: | PM-3 |
| Classification | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
| Applicant | DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXS |
| CFR Regulation Number | 870.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-01 |
| Decision Date | 1983-07-26 |