FDA Registration
Active
🇺🇸 United States
Primo Passi Ear and Forehead Thermomter
Reg #: 3034993050
·
FEI: 3034993050
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PRIMO PASSI
- Registration Number
- 3034993050
- FEI Number
- 3034993050
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2637 E Atlantic Blvd Pmb 1423
- City
- Pompano Beach
- State
- FL
- ZIP
- 33062
- Country
- US
Regulatory Submissions
- 510(k) Number
- K131243
Owner / Operator
- Firm Name
- Primo Passi
- Operator Number
- 10092542
- Address
- 2637 E. Atlantic Blvd
- City
- Pompano Beach
- State
- FL
- Postal Code
- 33062
- Country
- US
- Correspondent
- Yaluan M Giurizatto
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-03-14 |
Proprietary Names
Primo Passi Ear and Forehead Thermomter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility