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FDA 510(k)

OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE

K-Number: K920439 · 1992-09-04

ApplicantOmega Universal Technologies, Ltd.
Decision Date1992-09-04
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Omega Universal Technologies, Ltd.. It received FDA 510(k) clearance on 1992-09-04 under 510(k) number K920439. 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 OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE?

OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE is a medical device that received FDA 510(k) clearance on 1992-09-04. The listed applicant is Omega Universal Technologies, Ltd.. The 510(k) number is K920439.

When did OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE receive FDA 510(k) clearance?

OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE received FDA 510(k) clearance on 1992-09-04, under 510(k) number K920439.

Who is the listed applicant for OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE?

The FDA 510(k) record lists Omega Universal Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE?

The FDA product code for OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE is EOB.

Related Clinical Trials

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Other records listing Omega Universal Technologies, Ltd. 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.

K924228OMEGASCOPEK911090OMEGA ANGIOSCOPES (OMEGASCOPES)

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.

K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)Karl Storz SE & CO. KGK261544Hydro 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, LLC

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.

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