FDA-Device2019-09-11Class II

SonarMed AirWave Monitor, Model Number M0001

SonarMed Inc
Hazard

Potential for the presence of two error codes which would make the monitor inoperable.

Sold states
CA & TX
Affected count
16 units
Manufactured in
12220 N Meridian St Ste 150, N/A, Carmel, IN, United States
Products
SonarMed AirWave Monitor, Model Number M0001

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2450-2019

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