The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Pms-2 Pressure Monitor Separator.
| Device ID | K820912 |
| 510k Number | K820912 |
| Device Name: | PMS-2 PRESSURE MONITOR SEPARATOR |
| Classification | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
| Applicant | DELTA MEDICAL INDUSTRIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXS |
| CFR Regulation Number | 870.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-01 |
| Decision Date | 1982-05-18 |