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FDA 510(k)

PENTAX Medical Video Bronchoscope EB-J10 Series

K-Number: K200678 · 2020-07-30

ApplicantPentax of America, Inc.
Decision Date2020-07-30
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Video Bronchoscope EB-J10 Series is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2020-07-30 under approval number K200678. 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 EB-J10 Series?

PENTAX Medical Video Bronchoscope EB-J10 Series is a medical device that received FDA 510(k) clearance on 2020-07-30. It is manufactured by Pentax of America, Inc.. The 510(k) number is K200678.

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

PENTAX Medical Video Bronchoscope EB-J10 Series received FDA 510(k) clearance on 2020-07-30, under approval number K200678.

What company makes PENTAX Medical Video Bronchoscope EB-J10 Series?

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

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

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

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Related PubMed Literature

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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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