Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PENTAX Medical Video Bronchoscope EB-J10 Series

K-Number: K200678 · 2020-07-30

Decision Date2020-07-30
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Video Bronchoscope EB-J10 Series is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2020-07-30 under 510(k) 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. The listed applicant is Pentax of America, Inc.. The 510(k) number is K200678.

When did PENTAX Medical Video Bronchoscope EB-J10 Series receive FDA 510(k) clearance?

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

Who is the listed applicant for PENTAX Medical Video Bronchoscope EB-J10 Series?

The FDA 510(k) record lists Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Pentax of America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 39 devices →

Related Devices (Code: EOQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.