LPP

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

Device class

Class II (moderate risk)

Regulation

21 CFR 868.2500

Medical specialty

Anesthesiology

Adverse events (MAUDE)

1992: 1 · 1999: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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