FDA-Device2023-09-13Class III
ZVU Functional GI Software, REF: ZVU-3
Diversatek Healthcare
Hazard
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Sold states
worldwide - US Nationwide distribution in the states of NJ, MN, TN, WA, KY, OR, FL, GA, NY, TX, CO, KS and the countries of Japan, Saudi Arabia.
Affected count
20
Manufactured in
9150 Commerce Center Cir Ste 500, N/A, Highlands Ranch, CO, United States
Products
ZVU Functional GI Software, REF: ZVU-3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2521-2023Don't want to check this manually?
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