FDA-Device2019-07-10Class II
CLEO Patient Monitor /Tranquility VS Patient Monitor
Infinium Medical, Inc
Hazard
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
Sold states
Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin.
Affected count
95 devices
Manufactured in
12151 62nd St Ste 5, N/A, Largo, FL, United States
Products
CLEO Patient Monitor /Tranquility VS Patient Monitor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1926-2019Don't want to check this manually?
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