FDA Registration
Active
🇺🇸 United States
Thermo-Trace Infrared Thermometer
Reg #: 1055808
·
FEI: 1000110974
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PRIZM MEDICAL, INC.
- Registration Number
- 1055808
- FEI Number
- 1000110974
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 940 Sherwin Pkwy, Suite 100
- City
- Buford
- State
- GA
- ZIP
- 30518
- Country
- US
Regulatory Submissions
- 510(k) Number
- K012974
Owner / Operator
- Firm Name
- PRIZM MEDICAL, INC.
- Operator Number
- 9005746
- Address
- 940 Serwin Parkway, Suite 100
- City
- Buford
- State
- GA
- Postal Code
- 30518
- Country
- US
- Correspondent
- Jim Johnson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2008-06-10 |
Proprietary Names
Thermo-Trace Infrared Thermometer
Model #15053
Model #15045
Establishment Types
Repack or Relabel Medical Device