FDA 510(k)

PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

K-Number: K183516 · 2019-09-06

Decision Date2019-09-06

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-09-06 under approval number K183516. 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 Ultrasound Video Bronchoscope EB19-J10U?

PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is a medical device that received FDA 510(k) clearance on 2019-09-06. It is manufactured by Pentax of America, Inc.. The 510(k) number is K183516.

When was PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U approved by the FDA?

PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U received FDA 510(k) clearance on 2019-09-06, under approval number K183516.

What company makes PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U?

PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is manufactured by Pentax of America, Inc..

What is the FDA product code for PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U?

The FDA product code for PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is EOQ.

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Related PubMed Literature

PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

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

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