The following data is part of a premarket notification filed by Pace Tech Medical Monitors, Inc. with the FDA for Vitalmax 4000 Configured/vitalmax 4000 Modular/vitalmax 4100/minipack 3100/3000/vitalmax 800+/minipack 300.
| Device ID | K970445 |
| 510k Number | K970445 |
| Device Name: | VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PACE TECH MEDICAL MONITORS, INC. 510 GARDEN AVE. NORTH Clearwater, FL 34615 -4126 |
| Contact | Iihan M Bilgutay |
| Correspondent | Iihan M Bilgutay PACE TECH MEDICAL MONITORS, INC. 510 GARDEN AVE. NORTH Clearwater, FL 34615 -4126 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-05 |
| Decision Date | 1998-01-30 |