K-number	K260276
Device name	Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro
Applicant	Shenzhen AOJ Medical Technology Co., Ltd.
Product code	DXN
Device class	Class II
Decision date	Apr 1, 2026
Decision	Substantially Equivalent
Regulation	870.1130

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Arm Blood Pressure Monitor is a noninvasive device that measures systolic and diastolic blood pressure and pulse rate in adults using an oscillometric technique with an inflatable cuff wrapped around the upper arm. It is intended for use in medical facilities or at home and is available over-the-counter.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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