Data / Medical devices / United States / PharmaSmart International, LLC
PharmaSmart International, LLC: FDA-registered device maker in Rochester, NY, United States, 2 510(k) clearances
PharmaSmart International, LLC is registered with the FDA (registration 3007621003) in Rochester, NY, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 1, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007621003
- Address
- 125 Indigo Creek Drive Suite 10, Rochester, NY, United States, 14626
- Owner or operator
- PharmaSmart International, LLC (10029255)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- November 25, 2009
- Registered through
- 2026
- Brand names listed
- PS-1000 Blood Pressure Monitor, PS-1000LED Blood Pressure Monitor, PS-1500 Blood Pressure Monitor, PS-2000 Blood Pressure Monitor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Blood-Pressure | DSK | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 1, 2007 | K063137 | PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000 | DXN | Substantially Equivalent | Pharmasmart, Inc. | accessdata.fda.gov |
| June 30, 1981 | K811148 | VITA-STAT MODEL 9000-S | DSK | Substantially Equivalent | Viat-Stat | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Blood-Pressure
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
Updated May 1, 2007. 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.