Data / Medical devices / United States / Pacetech
Pacetech: FDA-registered device maker in Clearwater, FL, United States, 1 510(k) clearance
Pacetech is registered with the FDA (registration 3013314298) in Clearwater, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 30, 1998. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013314298
- FEI number
- 1051088
- Address
- 515 S MLK JR Ave, Clearwater, FL, United States, 33756
- Owner or operator
- PaceTech (10084234)
- Roles
- Manufacturer
- First device listed
- January 29, 2024
- Registered through
- 2026
- Brand names listed
- Minipack/VitalMax
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 30, 1998 | K970445 | VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300 | MHX | Substantially Equivalent | Pace Tech Medical Monitors, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 30, 1998. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.