FDA-Device2020-02-26Class II
Pentax Video Colonoscope Model: EC38-i10L
Pentax of America Inc
Hazard
Distributed in the USA without an approved 510K
Sold states
NC, MA
Affected count
1 unit
Manufactured in
3 Paragon Dr, Montvale, NJ, United States
Products
Pentax Video Colonoscope Model: EC38-i10L
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1268-2020Don't want to check this manually?
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