The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Pressure Monitor, Model 1131b.
| Device ID | K801110 |
| 510k Number | K801110 |
| Device Name: | PRESSURE MONITOR, MODEL 1131B |
| Classification | Computer, Blood-pressure |
| Applicant | AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-12 |
| Decision Date | 1980-05-20 |