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FDA 510(k)

OLYMPUS ISE MODULE FOR AU5000

K-Number: K893628 · 1989-08-11

ApplicantOlympus Corp.
Decision Date1989-08-11
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS ISE MODULE FOR AU5000 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1989-08-11 under 510(k) number K893628. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS ISE MODULE FOR AU5000?

OLYMPUS ISE MODULE FOR AU5000 is a medical device that received FDA 510(k) clearance on 1989-08-11. The listed applicant is Olympus Corp.. The 510(k) number is K893628.

When did OLYMPUS ISE MODULE FOR AU5000 receive FDA 510(k) clearance?

OLYMPUS ISE MODULE FOR AU5000 received FDA 510(k) clearance on 1989-08-11, under 510(k) number K893628.

Who is the listed applicant for OLYMPUS ISE MODULE FOR AU5000?

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

What is the FDA product code for OLYMPUS ISE MODULE FOR AU5000?

The FDA product code for OLYMPUS ISE MODULE FOR AU5000 is CGZ.

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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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