The following data is part of a premarket notification filed by Pace Tech, Inc. with the FDA for Vital System.
| Device ID | K880351 |
| 510k Number | K880351 |
| Device Name: | VITAL SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | PACE TECH, INC. 1060 CEPHAS RD. Clearwater, FL 34625 |
| Contact | Mary Bilgutay |
| Correspondent | Mary Bilgutay PACE TECH, INC. 1060 CEPHAS RD. Clearwater, FL 34625 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-03-22 |