The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Chamber, Mc-1 Disposable Pressure.
| Device ID | K781890 |
| 510k Number | K781890 |
| Device Name: | CHAMBER, MC-1 DISPOSABLE PRESSURE |
| 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 | 1978-11-06 |
| Decision Date | 1978-12-04 |