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TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR - Dw703

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091415

by Truly Instrument Co., Ltd.

Identifiers

510(k) Number
K091415 FDA 510(k)
FDA Product Code
DXN FDA 510(k)
Models / Variants
Dw100 FDA 510(k)
Dw200 FDA 510(k)
Dw500 FDA 510(k)
Dw700 FDA 510(k)
Dw703 FDA 510(k)
Dw701m.702m 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)

TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR - Dw703 by Truly Instrument Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 6 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Truly Instrument Co., Ltd.

Sources (1)

  • FDA 510(k) K091415 24 fields · synced Jun 18, 2026