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FDA 510(k)

NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS

K-Number: K943665 · 1994-10-11

ApplicantOlympus America, Inc.
Decision Date1994-10-11
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS 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 1994-10-11 under 510(k) number K943665. 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 NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS?

NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1994-10-11. The listed applicant is Olympus America, Inc.. The 510(k) number is K943665.

When did NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS receive FDA 510(k) clearance?

NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS received FDA 510(k) clearance on 1994-10-11, under 510(k) number K943665.

Who is the listed applicant for NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS?

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 NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS?

The FDA product code for NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS is EOB.

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Other records listing Olympus America, Inc. as applicant

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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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