Mcare 300 Vital Signs Monitor, Model 91220

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K062095 ↗

FDA Product Code

MHX

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What vital signs does the Mcare 300 Vital Signs Monitor Model 91220 measure?

  The Mcare 300 Vital Signs Monitor Model 91220 continuously monitors ECG, respiration, invasive and noninvasive blood pressure, body temperature, functional arterial oxygen saturation (SpO₂), and expired or inspired carbon dioxide (CO₂) levels. This comprehensive monitoring supports real-time clinical assessment across diverse patient populations, including adults, pediatric, and neonatal patients.

• Is the Mcare 300 Vital Signs Monitor Model 91220 reusable or single-use?

  The Mcare 300 Vital Signs Monitor Model 91220 is designed as a reusable medical device. It is intended for use in clinical settings such as hospitals, intensive care units, and emergency departments, where durability and repeated use are essential. Maintenance and storage instructions are provided in the manufacturer’s operations manual.

• What type of display does the Mcare 300 Vital Signs Monitor Model 91220 feature?

  The device features a 10.4-inch resistive touchscreen display, which allows for intuitive operation and clear visualization of patient data. This design enhances usability in fast-paced clinical environments.

• Is the Mcare 300 Vital Signs Monitor Model 91220 MRI-compatible?

  The Mcare 300 Vital Signs Monitor Model 91220 is not labeled as MRI-compatible. It is designed for use in environments where MRI safety is not a primary concern, meaning it should not be used in areas where MRI procedures are performed without additional safety assessments.

• Where can the Mcare 300 Vital Signs Monitor Model 91220 be used?

  This device is intended for use in clinical settings such as hospitals, intensive care units (ICUs), and emergency departments. Its robust design and comprehensive monitoring capabilities make it suitable for environments requiring continuous assessment of vital signs across various patient populations.