Micro-Processor Unit A3600AC

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

510(k) Number

K801762 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Micro-Processor Unit #A3600AC in clinical settings?

  The Micro-Processor Unit #A3600AC is designed as a microprocessor-based system to detect and alert for cardiac arrhythmias. It supports cardiovascular monitoring and diagnostic processes by identifying irregular heart rhythms, helping clinicians assess and respond to potential cardiac events in real-time.

• Is the Micro-Processor Unit #A3600AC intended for single-use or reusable applications?

  The device is explicitly described as a reusable medical instrument, meaning it is designed for repeated use in clinical environments after proper cleaning, maintenance, and sterilization procedures (if applicable). No details on sterilization are provided, so adherence to manufacturer guidelines is essential.

• How was the regulatory pathway for this device determined, and what does that mean for its use?

  The Micro-Processor Unit #A3600AC received FDA clearance under the Traditional 510(k) pathway, meaning it was deemed *substantially equivalent* to a legally marketed predicate device. This pathway confirms its compliance with FDA standards for safety and effectiveness as a Detector and Alarm, Arrhythmia device, ensuring it meets regulatory requirements for use in healthcare settings.

• Are there multiple models or size variations available for the Micro-Processor Unit #A3600AC?

  The provided data does not specify any size variations or distinct model numbers beyond the #A3600AC designation. The device is classified under product code DSI (Detector and Alarm, Arrhythmia), but no additional configurations or customizable features are mentioned.

• What type of healthcare environments is this device intended for, and how is it supplied?

  The Micro-Processor Unit #A3600AC is intended for use in healthcare environments, such as hospitals, clinics, or cardiac monitoring units where continuous or intermittent cardiovascular monitoring is required. While the device itself is reusable, the specific packaging or supply format (e.g., boxed, modular components) is not detailed in the available data.