The following data is part of a premarket notification filed by Pace Tech, Inc. with the FDA for Mini-pack 911 Series.
| Device ID | K912835 |
| 510k Number | K912835 |
| Device Name: | MINI-PACK 911 SERIES |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-26 |
| Decision Date | 1992-02-03 |