FDA-Device2023-11-08Class II
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Coapt LLC
Hazard
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Sold states
Worldwide distribution - US Nationwide and the country of Sweden.
Affected count
247 devices
Manufactured in
303 W Institute Pl Ste 200, N/A, Chicago, IL, United States
Products
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0203-2024Don't want to check this manually?
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