The following data is part of a premarket notification filed by Pace Tech, Inc. with the FDA for Minipack 3100/3000 Modification.
| Device ID | K934385 |
| 510k Number | K934385 |
| Device Name: | MINIPACK 3100/3000 MODIFICATION |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | PACE TECH, INC. 510 GARDEN AVE. NORTH Clearwater, FL 33755 |
| Contact | Mary J Bilgutay |
| Correspondent | Mary J Bilgutay PACE TECH, INC. 510 GARDEN AVE. NORTH Clearwater, FL 33755 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-09 |
| Decision Date | 1994-08-10 |