FDA Registration
Active
🇮🇳 India
CARDIOSOFT RESTING ECG
Reg #: 3007734888
·
FEI: 3007734888
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WIPRO GE HEALTHCARE PRIVATE Ltd.
- Registration Number
- 3007734888
- FEI Number
- 3007734888
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 122 (Part 1), JOHN F. WELCH TECHNOLOGY CENTRE, ODYSSEY AND GALILEO, EXPORT PROMOTIONAL INDUSTRIAL PARK, WHITEFIELD
- City
- BANGALORE Karnataka
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K103678
Owner / Operator
- Firm Name
- GE HealthCare Technologies Inc.
- Operator Number
- 9912004
- Address
- 3000 N. Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal Code
- 53188
- Country
- US
US Agent
- Business Name
- GE HealthCare Technologies, Inc
- Contact Name
- Tracey Holevas
- Address
- 3000 N. Grandview BLVD
- City
- Waukesha
- State
- WI
- ZIP
- 53188
- Country
- US
- [email protected]
- Phone
- 262 3092157
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2011-08-26 |
Proprietary Names
CARDIOSOFT RESTING ECG
CARDIOSOFT EXERCISE STRESS TEST
CARDIOSOFT WEB
CASE V6.6. Cardiac Testing System
CARDIOSOFT SERVER
CARDIOSOFT EKG VIEWER
CS V6.6. Cardiac Testing System
CASE
CS V6.71 Cardiac Testing System
CardioSoft V6.71. Cardiac Testing System
CASE V6.71. Cardiac Testing System
CASE V6.7
CARDIOSOFT CLIENT
CS V6.71
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility