510(k) K230145 ยท DXQ Blood Pressure Cuff
ONE-CUF
| Applicant | Ge Medical Systems Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Mar 14, 2023 |
| Received | Jan 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230145
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2024 | GE Medical Systems Information Technologies Inc GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers:
1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX;
2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - Open, Classified |
DXQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.