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H & L Full Automatic (nibp) Blood Pressure Monitor (Hl888ka +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K050491

by Health & Life Co., Ltd.

Identifiers

510(k) Number
K050491 FDA 510(k)
FDA Product Code
DXN FDA 510(k)
Models / Variants
Hl888ka FDA 510(k)
Hl888lf FDA 510(k)
Hl888if 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)

H & L Full Automatic (nibp) Blood Pressure Monitor (Hl888ka +2 more) by Health & Life 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

Manufacturer
Health & Life Co., Ltd.

Sources (1)

  • FDA 510(k) K050491 24 fields · synced Jun 19, 2026