Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait
Summary
Ge Medical Systems Information Technologies, Inc. received 510(k) clearance for Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O, a MWI device. Cleared on 2024-03-20.
Details
Source
510(k) Clearance
External ID
K234130
Action Date
2024-03-20
Status
Traditional
Category
device
Product Code
MWI
Product Description
Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O. Product code: MWI.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 534 device clearances issued this month. Ge Medical Systems Information Technologies, Inc. has received 13 total clearances in our database.
Ge Medical Systems Information Technologies, Inc. has 24 FDA actions in our database, including 11 recalls and 13 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Ge Medical Systems Information Technologies, Inc. have FDA actions?
Ge Medical Systems Information Technologies, Inc. has 24 FDA actions in our database, including 11 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K234130" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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