← Back to catalogue

Truly Automatic Wrist Blood Pressure Monitor (Dw100 +5 more)

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 (Dw100 +5 more) 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Truly Instrument Co., Ltd.

Sources (1)

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