FDA Registration
Active
🇺🇸 United States
PS-2000 Blood Pressure Monitor
Reg #: 3007621003
·
FEI: 3007621003
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PharmaSmart International, LLC
- Registration Number
- 3007621003
- FEI Number
- 3007621003
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 773 Elmgrove Rd, Bldg 2
- City
- Rochester
- State
- NY
- ZIP
- 14624
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063137
Owner / Operator
- Firm Name
- PharmaSmart International, LLC
- Operator Number
- 10029255
- Address
- 773 Elmgrove Road, Building 2
- City
- Rochester
- State
- NY
- Postal Code
- 14624
- Country
- US
- Correspondent
- Fred Sarkis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2009-11-25 |
Proprietary Names
PS-2000 Blood Pressure Monitor
PS-1000 Blood Pressure Monitor
PS-1500 Blood Pressure Monitor
PS-1000LED Blood Pressure Monitor
Establishment Types
Manufacture Medical Device