The following data is part of a premarket notification filed by Pace Tech, Inc. with the FDA for Vitalmax 800 Plus/vitalmax 810 Plus/minipack 300.
| Device ID | K945385 |
| 510k Number | K945385 |
| Device Name: | VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PACE TECH, INC. 510 GARDEN AVE. NORTH Clearwater, FL 33755 |
| Contact | B Ilgutay |
| Correspondent | B Ilgutay PACE TECH, INC. 510 GARDEN AVE. NORTH Clearwater, FL 33755 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-03 |
| Decision Date | 1995-01-31 |