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FDA 510(k)

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System

K-Number: K213235 · 2022-12-21

ApplicantPentax of America, Inc.
Decision Date2022-12-21
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2022-12-21 under approval number K213235. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System?

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Pentax of America, Inc.. The 510(k) number is K213235.

When was PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System approved by the FDA?

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System received FDA 510(k) clearance on 2022-12-21, under approval number K213235.

What company makes PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System?

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is manufactured by Pentax of America, Inc..

What is the FDA product code for PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System?

The FDA product code for PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is EOQ.

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Other Devices by Pentax of America, Inc.

K162151PENTAX Medical ENT Video Imaging System 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

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Related Devices (Code: EOQ)

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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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