CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
FDA 510(k) clearance K223531 · decided 2023-04-06
Clearance details
- K-number
- K223531
- Device name
- CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
- Applicant
- GE Healthcare Finland Oy
- Decision
- Substantially Equivalent
- Date received
- 2022-11-23
- Decision date
- 2023-04-06
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Helsinki, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142 recall (Z-2168-2024) | GE Healthcare Finland Oy | 2024-06-21 |
| CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; recall (Z-2169-2024) | GE Healthcare Finland Oy | 2024-06-21 |
| F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) recall (Z-2656-2023) | GE Medical Systems China Co., Ltd. | 2023-09-29 |