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FDA 510(k)

NASO-LARYNGO-PHARYNGOSCOPE

K-Number: K083553 · 2009-01-16

ApplicantSchoelly Imaging, Inc.
Decision Date2009-01-16
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NASO-LARYNGO-PHARYNGOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Schoelly Imaging, Inc.. It received FDA 510(k) clearance on 2009-01-16 under 510(k) number K083553. 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 NASO-LARYNGO-PHARYNGOSCOPE?

NASO-LARYNGO-PHARYNGOSCOPE is a medical device that received FDA 510(k) clearance on 2009-01-16. The listed applicant is Schoelly Imaging, Inc.. The 510(k) number is K083553.

When did NASO-LARYNGO-PHARYNGOSCOPE receive FDA 510(k) clearance?

NASO-LARYNGO-PHARYNGOSCOPE received FDA 510(k) clearance on 2009-01-16, under 510(k) number K083553.

Who is the listed applicant for NASO-LARYNGO-PHARYNGOSCOPE?

The FDA 510(k) record lists Schoelly Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NASO-LARYNGO-PHARYNGOSCOPE?

The FDA product code for NASO-LARYNGO-PHARYNGOSCOPE is EOB.

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Other records listing Schoelly Imaging, Inc. as applicant

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K090800VS-100 ILLUMINATION AND IMAGING SYSTEMK090601FSC 2K060899FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPEK053412FLEXISCOPE, MODELS 50MH AND 50 MHC

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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