FDA-Device2020-10-14Class III
Neoprobe GDS Control Unit, Model Number NPCU3
Devicor Medical Products Inc
Hazard
It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
Sold states
The products were distributed only to China.
Affected count
49
Manufactured in
300 E Business Way Fl 5, N/A, Cincinnati, OH, United States
Products
Neoprobe GDS Control Unit, Model Number NPCU3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0070-2021Don't want to check this manually?
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