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FDA 510(k)

FIBERVISION(TM)

K-Number: K895733 · 1989-11-21

ApplicantFiber Imaging, Inc.
Decision Date1989-11-21
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FIBERVISION(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Fiber Imaging, Inc.. It received FDA 510(k) clearance on 1989-11-21 under 510(k) number K895733. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBERVISION(TM)?

FIBERVISION(TM) is a medical device that received FDA 510(k) clearance on 1989-11-21. The listed applicant is Fiber Imaging, Inc.. The 510(k) number is K895733.

When did FIBERVISION(TM) receive FDA 510(k) clearance?

FIBERVISION(TM) received FDA 510(k) clearance on 1989-11-21, under 510(k) number K895733.

Who is the listed applicant for FIBERVISION(TM)?

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

What is the FDA product code for FIBERVISION(TM)?

The FDA product code for FIBERVISION(TM) is IYE.

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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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