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FDA 510(k)

DOFI RASTER-SCREEN

K-Number: K943554 · 1995-03-01

ApplicantHowrey & Simon
Decision Date1995-03-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DOFI RASTER-SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Howrey & Simon. It received FDA 510(k) clearance on 1995-03-01 under 510(k) number K943554. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOFI RASTER-SCREEN?

DOFI RASTER-SCREEN is a medical device that received FDA 510(k) clearance on 1995-03-01. The listed applicant is Howrey & Simon. The 510(k) number is K943554.

When did DOFI RASTER-SCREEN receive FDA 510(k) clearance?

DOFI RASTER-SCREEN received FDA 510(k) clearance on 1995-03-01, under 510(k) number K943554.

Who is the listed applicant for DOFI RASTER-SCREEN?

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

What is the FDA product code for DOFI RASTER-SCREEN?

The FDA product code for DOFI RASTER-SCREEN is GCJ.

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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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