FDA Registration
Active
🇺🇸 United States
T-STAT
Reg #: 3004957206
·
FEI: 3004957206
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- SPECTROS MEDICAL DEVICES INC
- Registration Number
- 3004957206
- FEI Number
- 3004957206
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2211 Norfolk St #1110
- City
- Houston
- State
- TX
- ZIP
- 77098
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192322
Owner / Operator
- Firm Name
- Spectros Medical Devices Inc
- Operator Number
- 9062042
- Address
- 2211 Norflolk St #1110
- City
- Houston
- State
- TX
- Postal Code
- 77098
- Country
- US
- Correspondent
- Ashley - Dynan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2019-10-16 |
Proprietary Names
T-STAT
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device