The following data is part of a premarket notification filed by Pace Tech, Inc. with the FDA for Vitalmax 800 Non-invasive Vital Sign Monitor/pulse.
| Device ID | K900451 |
| 510k Number | K900451 |
| Device Name: | VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | PACE TECH, INC. 1060 CEPHAS RD. Clearwater, FL 34625 |
| Contact | Mary J Bilgutay |
| Correspondent | Mary J Bilgutay PACE TECH, INC. 1060 CEPHAS RD. Clearwater, FL 34625 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-30 |
| Decision Date | 1990-07-18 |