FDA Registration
Active
🇺🇸 United States
Oximeter Acurio
Reg #: 3000206696
·
FEI: 3000206696
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HEALTHTEX DISTRIBUTORS, INC.
- Registration Number
- 3000206696
- FEI Number
- 3000206696
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3555 NW 41 Street
- City
- Miami
- State
- FL
- ZIP
- 33142
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180685
Owner / Operator
- Firm Name
- Healthtex Distributors, Inc.
- Operator Number
- 10027903
- Address
- 3555 NW 41 Street
- City
- Miami
- State
- FL
- Postal Code
- 33142
- Country
- US
- Correspondent
- Yvette Barreto
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-11-11 |
Proprietary Names
Oximeter Acurio
Establishment Types
Repack or Relabel Medical Device