Hp Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A, M3046A, M3015A, Rel.b

• • Ongoing Z-1722-2025 FDA Class II ·initiated 7 Apr 2025 ·via K993383, on the same 510(k)

  Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.

• • Terminated Z-2531-2020 FDA Class II ·initiated 8 Jun 2020

  Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867036).If they are connected to a host monitor, communication with the X3 or MMX could be disrupted, resulting in a loss of monitoring on the host monitor.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K993383 ↗

FDA Product Code

DSI

Models / Variants

M3000A

M3046A

M3015A

Rel.b

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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