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.)
Edan Diagnostics
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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