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Automatic Upper Arm Blood Pressure Monitor - BA-855X
FDA 510(k)Class II (US FDA 510(k))
510(k) K250231
Identifiers
- 510(k) Number
- K250231 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
- Models / Variants
- BA-831X FDA 510(k)BA-832X FDA 510(k)BA-833X FDA 510(k)BA-837X FDA 510(k)BA-838X FDA 510(k)BA-842X FDA 510(k)BA-843X FDA 510(k)BA-845X FDA 510(k)BA-847X FDA 510(k)BA-849X FDA 510(k)BA-851X FDA 510(k)BA-852X FDA 510(k)BA-855X FDA 510(k)BA-835 FDA 510(k)BA-836 FDA 510(k)BA-839 FDA 510(k)BA-840 FDA 510(k)BA-856 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 Upper Arm Blood Pressure Monitor - BA-855X by Dongguan E-Test Technology Co., Ltd — Class II — FDA_510K — listed in FDA 510(k) — 18 models
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 | K250231 | Class II | Active |
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Manufacturer
- Manufacturer
- Dongguan E-Test Technology Co., Ltd
- FDA Applicant
- Dongguan E-Test Technology Co., Ltd.
Sources (1)
- FDA 510(k) K250231 24 fields · synced Jun 18, 2026