RMU-2000 Automated Chest Compression System

• • Ongoing Z-2543-2024 FDA Class I ·initiated 12 Jul 2024

  Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.

510(k) Number

K211289 ↗

FDA Product Code

DRM

Device Class

Class II

Regulation

21 CFR Part 870.5200

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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