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Devices
Pentax Video Esophagoscopes
Model / Serial
EE-1580K A110273
Product Classification
Ear, Nose, and Throat Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
EE- Series Video Esophagoscopes, EE-1580K. || Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper Gastrointestinal Track.
Manufacturer
Pentax Medical Company
1 Event
Recall of Pentax Video Esophagoscopes
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Manufacturer
Pentax Medical Company
Manufacturer Address
Pentax Medical Company, 3 Paragon Dr, Montvale NJ 07645-1782
Manufacturer Parent Company (2017)
HOYA Corp.
Source
USFDA
Language
English
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