FDA-Device2018-08-01Class III
Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
Human Design Medical Llc
Hazard
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
Sold states
US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.
Affected count
45
Manufactured in
119 Braintree St Ste 703, N/A, Boston, MA, United States
Products
Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2530-2018Don't want to check this manually?
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