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FDA 510(k)

OLYMPUS NASAL AND SINUS ENDOSCOPES

K-Number: K944072 · 1995-01-11

ApplicantOlympus America, Inc.
Decision Date1995-01-11
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OLYMPUS NASAL AND SINUS ENDOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1995-01-11 under 510(k) number K944072. 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 OLYMPUS NASAL AND SINUS ENDOSCOPES?

OLYMPUS NASAL AND SINUS ENDOSCOPES is a medical device that received FDA 510(k) clearance on 1995-01-11. The listed applicant is Olympus America, Inc.. The 510(k) number is K944072.

When did OLYMPUS NASAL AND SINUS ENDOSCOPES receive FDA 510(k) clearance?

OLYMPUS NASAL AND SINUS ENDOSCOPES received FDA 510(k) clearance on 1995-01-11, under 510(k) number K944072.

Who is the listed applicant for OLYMPUS NASAL AND SINUS ENDOSCOPES?

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

What is the FDA product code for OLYMPUS NASAL AND SINUS ENDOSCOPES?

The FDA product code for OLYMPUS NASAL AND SINUS ENDOSCOPES is EOB.

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Other records listing Olympus America, Inc. as applicant

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K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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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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