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FDA 510(k)

PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock

K-Number: K231970 · 2024-01-12

Decision Date2024-01-12
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock 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 2024-01-12 under 510(k) number K231970. 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 Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock?

PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Pentax of America, Inc.. The 510(k) number is K231970.

When did PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock receive FDA 510(k) clearance?

PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock received FDA 510(k) clearance on 2024-01-12, under 510(k) number K231970.

Who is the listed applicant for PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock?

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 Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock?

The FDA product code for PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.