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FDA 510(k)

Rhinolaryngoscope system

K-Number: K232435 · 2024-04-26

ApplicantShenzhen HugeMed Medical Technical Development Co., Ltd.
Decision Date2024-04-26
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Rhinolaryngoscope system is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K232435. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rhinolaryngoscope system?

Rhinolaryngoscope system is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K232435.

When did Rhinolaryngoscope system receive FDA 510(k) clearance?

Rhinolaryngoscope system received FDA 510(k) clearance on 2024-04-26, under 510(k) number K232435.

Who is the listed applicant for Rhinolaryngoscope system?

The FDA 510(k) record lists Shenzhen HugeMed Medical Technical Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rhinolaryngoscope system?

The FDA product code for Rhinolaryngoscope system is EOB.

Other records listing Shenzhen HugeMed Medical Technical Development Co., Ltd. as applicant

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Related Devices (Code: EOB)

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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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