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FDA 510(k)

PENTAX Medical ENT Video Imaging System

K-Number: K162151 · 2017-04-20

ApplicantPentax of America, Inc.
Decision Date2017-04-20
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical ENT Video Imaging System is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2017-04-20 under approval number K162151. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX Medical ENT Video Imaging System?

PENTAX Medical ENT Video Imaging System is a medical device that received FDA 510(k) clearance on 2017-04-20. It is manufactured by Pentax of America, Inc.. The 510(k) number is K162151.

When was PENTAX Medical ENT Video Imaging System approved by the FDA?

PENTAX Medical ENT Video Imaging System received FDA 510(k) clearance on 2017-04-20, under approval number K162151.

What company makes PENTAX Medical ENT Video Imaging System?

PENTAX Medical ENT Video Imaging System is manufactured by Pentax of America, Inc..

What is the FDA product code for PENTAX Medical ENT Video Imaging System?

The FDA product code for PENTAX Medical ENT Video Imaging System is EOB.

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Other Devices by Pentax of America, Inc.

K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner K182004PENTAX Medical Endoscopic Ultrasound System K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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