FDA Registration
Active
🇺🇸 United States
APEXPRO RECEIVER SUBSYSTEM
Reg #: 3012359877
·
FEI: 3012359877
·
Expires 2025
Products
1
Proprietary Names
15
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GE Medical Systems Information Technologies, Inc.
- Registration Number
- 3012359877
- FEI Number
- 3012359877
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9900 Innovation Drive
- City
- Wauwatosa
- State
- WI
- ZIP
- 53226
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080251
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2010-06-30 |
Proprietary Names
APEXPRO RECEIVER SUBSYSTEM
APEXPRO QUAD RECEIVER MODULE
APEXPRO CH NONIN XPOD OXIMETER
ApexPro Telemetry System
ApexPro CH Transmitter
CARESCAPE T4 Transmitter
CARESCAPE Telemetry Server
CARESCAPE Telemetry T4 Transmitter
ApexPro FH Transceiver
CARESCAPE T14 Transmitter
CARESCAPE TELEMETRY SERVER V4 UPGRADE
CARESCAPE Telemetry Server V4
ApexPro 600 MHz Receiver
ApexPro 400 MHz Receiver
CARESCAPE TELEMETRY SYSTEM
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility