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
FDA 510(k) clearance K213234 · decided 2022-04-12
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-30
- Decision date
- 2022-04-12
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wauwatosa, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affe recall (Z-0454-2026) | GE Healthcare Finland Oy | 2025-11-07 |