Ge Medical Systems Information Technologies, Inc. · Class II · Cleared Apr 12, 2022
| K-number | K213234 |
| Device name | 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 |
| Applicant | Ge Medical Systems Information Technologies, Inc. |
| Product code | MHX |
| Device class | Class II |
| Decision date | Apr 12, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 870.1025 |
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