FDA Registration
Active
🇨🇷 Costa Rica
EnSite LiveView Dynamic Display Software License
Reg #: 3008452825
·
FEI: 3008452825
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Abbott Medical Costa Rica Ltda.
- Registration Number
- 3008452825
- FEI Number
- 3008452825
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Edificio #44 Calle 0, Ave. 2, Zona Franca Coyol
- City
- El Coyol Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K201148
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2020-06-30 |
Proprietary Names
EnSite LiveView Dynamic Display Software License
EnSite Precision Software Installation v2.6
EnSite Precision Software Upgrade v2.7.1
EnSite Precision Software Installation v.2.7 H702701
EnSite Precision System Software Upgrade v.2.6.1, H702602
EnSite Precision Surface Electrode Kit EN0020-p
Establishment Types
Manufacture Medical Device