FDA Registration
Active
🇺🇸 United States
IRIS 400
Reg #: 3006111110
·
FEI: 3006111110
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDITHERM INC.
- Registration Number
- 3006111110
- FEI Number
- 3006111110
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5353 Wyoming BLVD NE, Suite D
- City
- Albuquerque
- State
- NM
- ZIP
- 87108
- Country
- US
Regulatory Submissions
- 510(k) Number
- K003332
Owner / Operator
- Firm Name
- MEDITHERM INC.
- Operator Number
- 9096265
- Address
- 1603 Capitol Ave, Suite 310, # A175
- City
- Cheyenne
- State
- WY
- Postal Code
- 82001
- Country
- US
- Correspondent
- PETER - LEANDO
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Telethermographic (Adjunctive Use) | LHQ | Class 1 | Obstetrics/Gynecology | No | 2007-01-04 |
Proprietary Names
IRIS 400
IRIS 200
FS 520
IRIS 160
MED2000 IRIS
MED2000
MED2000 Pro
MED2000 IRIS Elite
Establishment Types
Manufacture Medical Device