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FDA 510(k)

GASTROSCAN

K-Number: K905154 · 1991-06-19

Decision Date1991-06-19
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GASTROSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Medics Instrument Corp.. It received FDA 510(k) clearance on 1991-06-19 under 510(k) number K905154. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GASTROSCAN?

GASTROSCAN is a medical device that received FDA 510(k) clearance on 1991-06-19. The listed applicant is Medics Instrument Corp.. The 510(k) number is K905154.

When did GASTROSCAN receive FDA 510(k) clearance?

GASTROSCAN received FDA 510(k) clearance on 1991-06-19, under 510(k) number K905154.

Who is the listed applicant for GASTROSCAN?

The FDA 510(k) record lists Medics Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GASTROSCAN?

The FDA product code for GASTROSCAN is FFX.

Related Clinical Trials

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.

Other records listing Medics Instrument Corp. 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.

Related Devices (Code: FFX)

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.

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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