The following data is part of a premarket notification filed by Y with the FDA for Ivac #1160 Multiple Vital Signs Unit.
| Device ID | K820569 |
| 510k Number | K820569 |
| Device Name: | IVAC #1160 MULTIPLE VITAL SIGNS UNIT |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Y 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-02 |
| Decision Date | 1982-03-18 |