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FDA 510(k)

THE SCREENER GSI 55 ABR SCREENER

K-Number: K870030 · 1987-03-13

ApplicantGrason-Stadler, Inc.
Decision Date1987-03-13
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THE SCREENER GSI 55 ABR SCREENER is the device name listed in this FDA 510(k) record. The listed applicant is Grason-Stadler, Inc.. It received FDA 510(k) clearance on 1987-03-13 under 510(k) number K870030. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE SCREENER GSI 55 ABR SCREENER?

THE SCREENER GSI 55 ABR SCREENER is a medical device that received FDA 510(k) clearance on 1987-03-13. The listed applicant is Grason-Stadler, Inc.. The 510(k) number is K870030.

When did THE SCREENER GSI 55 ABR SCREENER receive FDA 510(k) clearance?

THE SCREENER GSI 55 ABR SCREENER received FDA 510(k) clearance on 1987-03-13, under 510(k) number K870030.

Who is the listed applicant for THE SCREENER GSI 55 ABR SCREENER?

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

What is the FDA product code for THE SCREENER GSI 55 ABR SCREENER?

The FDA product code for THE SCREENER GSI 55 ABR SCREENER is GWJ.

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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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