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FDA 510(k)

ENT Nasopharyngoscope and Accessories

K-Number: K214050 · 2022-07-01

ApplicantMedimaging Integrated Solution, Inc (Miis)
Decision Date2022-07-01
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENT Nasopharyngoscope and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Medimaging Integrated Solution, Inc (Miis). It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K214050. 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 ENT Nasopharyngoscope and Accessories?

ENT Nasopharyngoscope and Accessories is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Medimaging Integrated Solution, Inc (Miis). The 510(k) number is K214050.

When did ENT Nasopharyngoscope and Accessories receive FDA 510(k) clearance?

ENT Nasopharyngoscope and Accessories received FDA 510(k) clearance on 2022-07-01, under 510(k) number K214050.

Who is the listed applicant for ENT Nasopharyngoscope and Accessories?

The FDA 510(k) record lists Medimaging Integrated Solution, Inc (Miis) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENT Nasopharyngoscope and Accessories?

The FDA product code for ENT Nasopharyngoscope and Accessories is EOB.

Other records listing Medimaging Integrated Solution, Inc (Miis) 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.

K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video BoxK223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxK193188MiiS Horus Eye Anterior CameraK181260MiiS Horus Scope DPT 100K170470Digital Eye Anterior Camera

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Related Devices (Code: EOB)

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.

K261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, LLCK243639Portare System (FA-001)Grumpy Innovation, Inc.

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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