The following data is part of a premarket notification filed by Pace Tech Medical Monitors, Inc. with the FDA for Vitalmax 840 Series.
| Device ID | K914164 |
| 510k Number | K914164 |
| Device Name: | VITALMAX 840 SERIES |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | PACE TECH MEDICAL MONITORS, INC. 510 GARDEN AVE.NORTH Clearwater, FL 34615 -4126 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-17 |
| Decision Date | 1993-04-09 |