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FDA 510(k)

POC ENT ENDOSCOPE - SINUSCOPE

K-Number: K983123 · 1998-09-25

ApplicantPrecision Optics Corp.
Decision Date1998-09-25
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

POC ENT ENDOSCOPE - SINUSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Precision Optics Corp.. It received FDA 510(k) clearance on 1998-09-25 under 510(k) number K983123. 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 POC ENT ENDOSCOPE - SINUSCOPE?

POC ENT ENDOSCOPE - SINUSCOPE is a medical device that received FDA 510(k) clearance on 1998-09-25. The listed applicant is Precision Optics Corp.. The 510(k) number is K983123.

When did POC ENT ENDOSCOPE - SINUSCOPE receive FDA 510(k) clearance?

POC ENT ENDOSCOPE - SINUSCOPE received FDA 510(k) clearance on 1998-09-25, under 510(k) number K983123.

Who is the listed applicant for POC ENT ENDOSCOPE - SINUSCOPE?

The FDA 510(k) record lists Precision Optics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POC ENT ENDOSCOPE - SINUSCOPE?

The FDA product code for POC ENT ENDOSCOPE - SINUSCOPE is EOB.

Related Clinical Trials

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.

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Other records listing Precision Optics Corp. 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.

K053425PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOSK945684POC ARTHROSCOPE AND ACCESSORIES

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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