FDA Registration
Active
🇺🇸 United States
Etiometry Platform Software
Reg #: 3011683100
·
FEI: 3011683100
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ETIOMETRY INC.
- Registration Number
- 3011683100
- FEI Number
- 3011683100
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 280 Summer St., 4th Floor
- City
- Boston
- State
- MA
- ZIP
- 02210
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223578
Owner / Operator
- Firm Name
- Etiometry Inc.
- Operator Number
- 10049448
- Address
- 280 Summer St., 4th Floor
- City
- Boston
- State
- MA
- Postal Code
- 02210
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Adjunctive Cardiovascular Status Indicator | PPW | Class 2 | Cardiovascular | No | 2023-09-06 |
Proprietary Names
Etiometry Platform Software
Establishment Types
Manufacture Medical Device