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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 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 2019-09-06 under 510(k) 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. The listed applicant is Pentax of America, Inc.. The 510(k) number is K183516.

When did PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U receive FDA 510(k) clearance?

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

Who is the listed applicant for PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U?

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 Ultrasound Video Bronchoscope EB19-J10U?

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

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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

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