FDA-Device2014-08-27Class II
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Pentax Medical Company
Hazard
The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
Sold states
Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.
Affected count
98 units US; 1108 units OUS
Manufactured in
3 Paragon Dr, Montvale, NJ, United States
Products
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2290-2014Don't want to check this manually?
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