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FDA 510(k)

HD-550 Video Endoscope System

K-Number: K211882 · 2022-04-01

ApplicantSonoscape Medical Corp.
Decision Date2022-04-01
Product CodeNWB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HD-550 Video Endoscope System is a medical device manufactured by Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2022-04-01 under approval number K211882. The device is classified under product code NWB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HD-550 Video Endoscope System?

HD-550 Video Endoscope System is a medical device that received FDA 510(k) clearance on 2022-04-01. It is manufactured by Sonoscape Medical Corp.. The 510(k) number is K211882.

When was HD-550 Video Endoscope System approved by the FDA?

HD-550 Video Endoscope System received FDA 510(k) clearance on 2022-04-01, under approval number K211882.

What company makes HD-550 Video Endoscope System?

HD-550 Video Endoscope System is manufactured by Sonoscape Medical Corp..

What is the FDA product code for HD-550 Video Endoscope System?

The FDA product code for HD-550 Video Endoscope System is NWB.

Related Clinical Trials

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Sonoscape Medical Corp.

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Related Devices (Code: NWB)

K173921HD-500 Video Endoscope SystemSonoscape Medical Corp. K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.

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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