← Product Code [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN) · K260276

# 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 (K260276)

_Shenzhen AOJ Medical Technology Co., Ltd. · DXN · Apr 1, 2026 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K260276

## Device Facts

- **Applicant:** Shenzhen AOJ Medical Technology Co., Ltd.
- **Product Code:** [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN.md)
- **Decision Date:** Apr 1, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.1130
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K260276](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K260276)

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