ONE-CUF
FDA 510(k) clearance K230145 · decided 2023-03-14
Clearance details
- K-number
- K230145
- Device name
- ONE-CUF
- Applicant
- Ge Medical Systems Information Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-01-18
- Decision date
- 2023-03-14
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- DXQ
- Device class
- 2
- Regulation number
- 870.1120
- 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 |
|---|---|---|
| GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, recall (Z-2027-2024) | GE Medical Systems Information Technologies Inc | 2024-06-06 |