The following data is part of a premarket notification filed by Zatek with the FDA for Pressure Monitor, Model 212.
| Device ID | K790302 |
| 510k Number | K790302 |
| Device Name: | PRESSURE MONITOR, MODEL 212 |
| Classification | Dynamometer, Nonpowered |
| Applicant | ZATEK 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRW |
| CFR Regulation Number | 888.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-13 |
| Decision Date | 1979-03-21 |