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FDA 510(k)

GABRIEL DIGITREND

K-Number: K822795 · 1982-10-08

ApplicantGabriel Ent.
Decision Date1982-10-08
Product CodeHCS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GABRIEL DIGITREND is the device name listed in this FDA 510(k) record. The listed applicant is Gabriel Ent.. It received FDA 510(k) clearance on 1982-10-08 under 510(k) number K822795. The device is classified under product code HCS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GABRIEL DIGITREND?

GABRIEL DIGITREND is a medical device that received FDA 510(k) clearance on 1982-10-08. The listed applicant is Gabriel Ent.. The 510(k) number is K822795.

When did GABRIEL DIGITREND receive FDA 510(k) clearance?

GABRIEL DIGITREND received FDA 510(k) clearance on 1982-10-08, under 510(k) number K822795.

Who is the listed applicant for GABRIEL DIGITREND?

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

What is the FDA product code for GABRIEL DIGITREND?

The FDA product code for GABRIEL DIGITREND is HCS.

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 Gabriel Ent. 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: HCS)

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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