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FDA 510(k)

GSI 70 AUDIOPATH SCREENER

K-Number: K974237 · 1998-02-10

ApplicantGrason-Stadler, Inc.
Decision Date1998-02-10
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GSI 70 AUDIOPATH 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 1998-02-10 under 510(k) number K974237. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSI 70 AUDIOPATH SCREENER?

GSI 70 AUDIOPATH SCREENER is a medical device that received FDA 510(k) clearance on 1998-02-10. The listed applicant is Grason-Stadler, Inc.. The 510(k) number is K974237.

When did GSI 70 AUDIOPATH SCREENER receive FDA 510(k) clearance?

GSI 70 AUDIOPATH SCREENER received FDA 510(k) clearance on 1998-02-10, under 510(k) number K974237.

Who is the listed applicant for GSI 70 AUDIOPATH 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 GSI 70 AUDIOPATH SCREENER?

The FDA product code for GSI 70 AUDIOPATH SCREENER is EWO.

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Related Devices (Code: EWO)

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

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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