DeviceClearance

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— 510(k) K213234

Substantially Equivalent

Ge Medical Systems Information Technologies, Inc.

FDA 510(k) clearance K213234 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, Substantially Equivalent on 2022-04-12. Applicant: Ge Medical Systems Information Technologies, Inc.. Device class: 2.

Clearance details

Applicant
Ge Medical Systems Information Technologies, Inc.
Product code
Product code MHX
Device class
Class 2
Regulation
21 CFR 870.1025
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wauwatosa, WI, US
Download summary PDFView on FDA.gov ↗

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More clearances from Ge Medical Systems Information Technologies, Inc.

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Adverse events under product code MHX

product code MHX
Death
580
Injury
2,441
Malfunction
12,655
Other
3
Total
15,679

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K213234

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213234.

Data sourced from openFDA. This site is unofficial and independent of the FDA.