CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP,
Summary
Ge Medical Systems Information Technologies, Inc. received 510(k) clearance for CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201, a MHX device. Cleared on 2022-04-12.
Details
Source
510(k) Clearance
External ID
K213234
Action Date
2022-04-12
Status
Traditional
Category
device
Product Code
MHX
Product Description
CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201. Product code: MHX.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 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 "K213234" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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