The following data is part of a premarket notification filed by Norton Texas Medical Products with the FDA for Pressure Monitor.
| Device ID | K842194 |
| 510k Number | K842194 |
| Device Name: | PRESSURE MONITOR |
| Classification | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
| Applicant | NORTON TEXAS MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Contact | Rick Foster |
| Correspondent | Rick Foster NORTON TEXAS MEDICAL PRODUCTS 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 | 1984-06-04 |
| Decision Date | 1984-08-27 |