Cardiosoft V7 Cardiac Testing System K231870 — Device overview

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Proprietary Name

CardioSoft V7 Cardiac Testing System

Class 2 (Moderate Risk)

Device Name

Computer, Diagnostic, Programmable

Primary Manufacturer

GE Medical Systems Information Technologies Inc.

Specialty

Cardiovascular

Device Information

The K Number is a unique identifier assigned by the FDA for tracking medical devices. The Regulation Number references the specific FDA regulation that governs the device, confirming its registration and compliance with FDA standards for easy regulatory verification.

Source
K Number
K231870
Unique FDA identifier
Regulation Number
870.1425
FDA regulation reference

Manufacturer Information

The Manufacturer Information section includes details about the primary manufacturer of the device, including their name and location. If applicable, it also lists the US Agent responsible for representing the manufacturer in the United States. The agent’s contact information, such as email and phone number, is provided for further communication. Additionally, the Registration Addresses section shows where the manufacturer is located worldwide and includes information about their registration status and validity, such as the Expiry Year of their registration and the establishment type (e.g., manufacturing medical devices).

Source

Registration Addresses

6 registered establishments worldwide

Registration Name
WIPRO GE HEALTHCARE PRIVATE Ltd.
Expiry year
2026
Registration Number
3007734888
Address
122 (Part 1), JOHN F. WELCH TECHNOLOGY CENTRE, ODYSSEY AND GALILEO
EXPORT PROMOTIONAL INDUSTRIAL PARK, WHITEFIELD
BANGALORE Karnataka560066
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Registration Name
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
Expiry year
2026
Registration Number
1651104
Address
465 PAN AMERICAN DR STE 11
EL PASO, TX79907
Establishment Types
Manufacture Medical Device
Registration Name
GE HEALTHCARE FINLAND OY
Expiry year
2026
Registration Number
9610105
Address
KUORTANEENKATU 2
HELSINKI UusimaaFIN-00510
Establishment Types
Manufacture Medical Device
Registration Name
GE Medical Systems Information Technologies Critikon de Mexico S. de R.L. de C.V.
Expiry year
2026
Registration Number
3008729547
Address
CALLE VALLE DEL CEDRO 1551
JUAREZ Chihuahua32575
Establishment Types
Manufacture Medical Device
Registration Name
GE Medical Systems Information Technologies Inc.
Expiry year
2026
Registration Number
3001570235
Address
3114 N Grandview Blvd
Waukesha, WI53188
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Registration Name
GE Medical Systems Information Technologies Inc.
Expiry year
2026
Registration Number
3012359877
Address
9900 Innovation Drive
Wauwatosa, WI53226
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility

Owner/Operator Information

The Owner/Operator Information section provides details about the company or entity responsible for the device. It typically includes the company name of the device's owner or operator, as well as the business address, which is the primary location where the business operates or is registered. This information helps identify the entity managing or manufacturing the device and provides transparency regarding the responsible party for regulatory purposes.

Source
Company Name
GE HealthCare Technologies Inc.
Device owner/operator
Business Address
3000 N. Grandview Blvd Waukesha, WI 53188
Primary business location