EWC

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Chamber, Acoustic (For Audiometric Testing)

Device class

Class I (low risk)

Regulation

21 CFR 874.1060

Medical specialty

Ear, Nose, Throat

Adverse events (MAUDE)

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

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