The following data is part of a premarket notification filed by Pace Tech, Inc. with the FDA for Vitalmax 4000/minipack 3100/3000.
| Device ID | K951226 |
| 510k Number | K951226 |
| Device Name: | VITALMAX 4000/MINIPACK 3100/3000 |
| Classification | Computer, Blood-pressure |
| Applicant | PACE TECH, INC. 510 GARDEN AVE. NORTH Clearwater, FL 33755 |
| Contact | Ilhan M Bilgutay |
| Correspondent | Ilhan M Bilgutay PACE TECH, INC. 510 GARDEN AVE. NORTH Clearwater, FL 33755 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-20 |
| Decision Date | 1996-11-21 |