FDA Registration
Active
🇺🇸 United States
Electrocardiograph
Reg #: 2024089
·
FEI: 2024089
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ACS Diagnostics, INC.
- Registration Number
- 2024089
- FEI Number
- 2024089
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 Hughes
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K860249
Owner / Operator
- Firm Name
- Applied Cardiac Systems, Inc.
- Operator Number
- 2024089
- Address
- 1 Hughes, --
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- LOREN A MANERA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2000-06-23 |
Proprietary Names
Electrocardiograph
Establishment Types
Manufacture Medical Device