MRP

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Analyzer, Nitric Oxide

Device class

Class II (moderate risk)

Regulation

21 CFR 868.2380

Medical specialty

Anesthesiology

Adverse events (MAUDE)

2011: 8 · 2013: 7 · 2014: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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