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Automatic Electronic Blood Pressure Monitor (U90B series (including ( U90B +7 m…
FDA 510(k)Class II (US FDA 510(k))
510(k) K260273
Identifiers
- 510(k) Number
- K260273 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
- Models / Variants
- including ( U90B FDA 510(k)U90B Pro FDA 510(k)U90B Plus FDA 510(k)U90B Ultra FDA 510(k)U90C FDA 510(k)U90C Pro FDA 510(k)U90C Plus FDA 510(k)U90C Ultra).) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Automatic Electronic Blood Pressure Monitor (U90B series (including ( U90B +7 m… by Shenzhen Urion Technology Co., Ltd. — Class II — FDA_510K — listed in FDA…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260273 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Urion Technology Co., Ltd.
Sources (1)
- FDA 510(k) K260273 24 fields · synced Jun 18, 2026