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
K213234 is the FDA 510(k) clearance record 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 class II device, cleared for Ge Medical Systems Information Technologies, Inc. on under FDA product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, Inc., from to . As of , FDA records show one recall naming K213234.
Clearance record
- Decision date
- Received
- (194 days to decision)
- Product code
- MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Regulation
- 21 CFR 870.1025
- Device class
- Class II
- Review panel
- Cardiovascular
- Applicant
- Ge Medical Systems Information Technologies, Inc. 9900 Innovation Dr., Wauwatosa WI
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code MHX
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 1 |
| January 2026 | 1 |
| February 2026 | 1 |
| March 2026 | 0 |
| April 2026 | 3 |
| May 2026 | 2 |
| June 2026 | 1 |
| July 2026 | 1 |
| August 2026 | 3 |
| September 2026 | 1 |
| October 2026 | 0 |
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