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FDA 510(k)

PENTAX Medical Video Bronchoscope EB11-J10

K-Number: K210928 · 2021-10-21

ApplicantPentax of America, Inc.
Decision Date2021-10-21
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Video Bronchoscope EB11-J10 is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2021-10-21 under approval number K210928. 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 Video Bronchoscope EB11-J10?

PENTAX Medical Video Bronchoscope EB11-J10 is a medical device that received FDA 510(k) clearance on 2021-10-21. It is manufactured by Pentax of America, Inc.. The 510(k) number is K210928.

When was PENTAX Medical Video Bronchoscope EB11-J10 approved by the FDA?

PENTAX Medical Video Bronchoscope EB11-J10 received FDA 510(k) clearance on 2021-10-21, under approval number K210928.

What company makes PENTAX Medical Video Bronchoscope EB11-J10?

PENTAX Medical Video Bronchoscope EB11-J10 is manufactured by Pentax of America, Inc..

What is the FDA product code for PENTAX Medical Video Bronchoscope EB11-J10?

The FDA product code for PENTAX Medical Video Bronchoscope EB11-J10 is EOQ.

Related Clinical Trials

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Related PubMed Literature

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.

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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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