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FDA 510(k)

ENTity WiFi Video Nasopharyngoscope System

K-Number: K200609 · 2021-01-13

ApplicantOptim, LLC
Decision Date2021-01-13
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENTity WiFi Video Nasopharyngoscope System is a medical device manufactured by Optim, LLC. It received FDA 510(k) clearance on 2021-01-13 under approval number K200609. 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 ENTity WiFi Video Nasopharyngoscope System?

ENTity WiFi Video Nasopharyngoscope System is a medical device that received FDA 510(k) clearance on 2021-01-13. It is manufactured by Optim, LLC. The 510(k) number is K200609.

When was ENTity WiFi Video Nasopharyngoscope System approved by the FDA?

ENTity WiFi Video Nasopharyngoscope System received FDA 510(k) clearance on 2021-01-13, under approval number K200609.

What company makes ENTity WiFi Video Nasopharyngoscope System?

ENTity WiFi Video Nasopharyngoscope System is manufactured by Optim, LLC.

What is the FDA product code for ENTity WiFi Video Nasopharyngoscope System?

The FDA product code for ENTity WiFi Video Nasopharyngoscope System is EOB.

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 Optim, LLC

K254133ENTity USB Videoscope System

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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