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Full Automatic (nibp) Blood Pressure Monitor (Hl888ea +3 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042853

by Health & Life Co., Ltd.

Identifiers

510(k) Number
K042853 FDA 510(k)
FDA Product Code
DXN FDA 510(k)
Models / Variants
Hl888ea FDA 510(k)
Hl888cf FDA 510(k)
Hl888gf FDA 510(k)
Hl888qa 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)

Full Automatic (nibp) Blood Pressure Monitor (Hl888ea +3 more) by Health & Life Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 4 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) K042853 24 fields · synced Jun 18, 2026