FlexView Clinical Monitoring System Modification

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

Full name

Modification to Flexview Clinical Monitoring System

510(k) Number

K011999 ↗

FDA Product Code

MSX

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Alarmview Wireless Data Network System

  Class II

  FDA 510(k) K010912 Active Cleared 5 Apr 2001

• Mobile-Patient Viewer

  Class II

  FDA 510(k) K011436 Active Cleared 5 Jul 2001

• Flexview Clinical Monitoring System

  Class II

  FDA 510(k) K003998 Active Cleared 7 Mar 2001

• (Vcom, Irvs, Rvs) Central Monitoring Station, V-Link or Ambulatory Transmitters and Arrhytmia Detector and Alarms with

  Class II

  FDA 510(k) K962473 Active Cleared 6 Nov 1997

• Cardio-Pager System

  Class II

  FDA 510(k) K973527 Active Cleared 31 Mar 1998

• Modification to Alarmview Wireless Data Network System

  Class II

  FDA 510(k) K013156 Active Cleared 19 Oct 2001

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• What clinical environments is the FlexView Clinical Monitoring System Modification designed for?

  The FlexView Clinical Monitoring System Modification is specifically designed for use in healthcare facilities such as hospitals and standalone surgical centers. It is intended to provide real-time patient monitoring in settings where aggregated vital signs from multiple devices are needed for remote observation and management.

• Is the FlexView Clinical Monitoring System Modification a single-use or reusable device?

  The FlexView Clinical Monitoring System Modification is supplied as a reusable system. It requires proper calibration and maintenance in accordance with the manufacturer’s guidelines to ensure accurate and reliable performance over multiple uses.

• What types of devices can the FlexView Clinical Monitoring System Modification integrate with?

  The FlexView Clinical Monitoring System Modification integrates with compatible pulse oximeters, infusion pumps, and ventilators. This integration allows it to aggregate and display vital signs from these devices, enabling comprehensive patient monitoring.

• How is the regulatory status of the FlexView Clinical Monitoring System Modification determined?

  The FlexView Clinical Monitoring System Modification holds a Substantially Equivalent (SESE) determination by the FDA’s Cardiovascular Advisory Committee under a Special 510(k) clearance (K011999). It is classified as a Class II device under FDA regulation 870.2300, reflecting its intended use for real-time patient monitoring in clinical settings.

• What maintenance or calibration requirements apply to the FlexView Clinical Monitoring System Modification?

  Since the FlexView Clinical Monitoring System Modification is reusable, it must undergo proper calibration and maintenance as outlined by the manufacturer. Regular upkeep ensures accurate monitoring and compliance with clinical standards, particularly when integrating with pulse oximeters, infusion pumps, or ventilators.