MLD

14 FDA 510(k) clearances · Product code

FDA profile

Official device name

Monitor, St Segment With Alarm

Device class

Class II (moderate risk)

Regulation

21 CFR 870.1025

Medical specialty

Cardiovascular

Adverse events (MAUDE)

2007: 3 · 2008: 5 · 2009: 3 · 2011: 6 · 2012: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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