FDA-Device2020-02-26Class II
EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)
Hazard
Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.
Sold states
U.S. Nationwide distribution in the state of CA.
Affected count
7 units
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1256-2020Don't want to check this manually?
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