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Automatic Blood Pressure Monitor (LD-562U +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K170454

by HONSUN (NANTONG) Co., Ltd.

Identifiers

510(k) Number
K170454 FDA 510(k)
FDA Product Code
DXN FDA 510(k)
Models / Variants
LD-562U FDA 510(k)
LD-588U FDA 510(k)
LD-533U 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 Blood Pressure Monitor (LD-562U +2 more) by HONSUN (NANTONG) Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 3 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K170454 24 fields · synced Jun 18, 2026