Ya Horng Arm Type Digital Blood Pressure Monitor (Bp-600 +6 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K081590

Identifiers

510(k) Number: K081590 FDA 510(k)
FDA Product Code: DXN FDA 510(k)
Models / Variants: Bp-600 FDA 510(k)
Bp-600r FDA 510(k)
Bp-600u FDA 510(k)
Bp-600b FDA 510(k)
Bp-600rb FDA 510(k)
Bp-600ub FDA 510(k)
Bp-600j 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)

Ya Horng Arm Type Digital Blood Pressure Monitor (Bp-600 +6 more) by Ya Horng Electronic Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 7 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	K081590	Class II	Active

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Manufacturer

Manufacturer: Ya Horng Electronic Co., Ltd.

Sources (1)

FDA 510(k) K081590 24 fields · synced Jun 18, 2026