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FDA 510(k)

FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE

K-Number: K895320 · 1989-11-01

ApplicantDigivision, Inc.
Decision Date1989-11-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE is the device name listed in this FDA 510(k) record. The listed applicant is Digivision, Inc.. It received FDA 510(k) clearance on 1989-11-01 under 510(k) number K895320. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE?

FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE is a medical device that received FDA 510(k) clearance on 1989-11-01. The listed applicant is Digivision, Inc.. The 510(k) number is K895320.

When did FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE receive FDA 510(k) clearance?

FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE received FDA 510(k) clearance on 1989-11-01, under 510(k) number K895320.

Who is the listed applicant for FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE?

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

What is the FDA product code for FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE?

The FDA product code for FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE is LLZ.

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Other records listing Digivision, Inc. 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.

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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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