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FDA 510(k)

ARTIUS SYSTEM

K-Number: K771151 · 1977-08-04

ApplicantGeneral Electric Co.
Decision Date1977-08-04
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ARTIUS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1977-08-04 under 510(k) number K771151. The device is classified under product code HGL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTIUS SYSTEM?

ARTIUS SYSTEM is a medical device that received FDA 510(k) clearance on 1977-08-04. The listed applicant is General Electric Co.. The 510(k) number is K771151.

When did ARTIUS SYSTEM receive FDA 510(k) clearance?

ARTIUS SYSTEM received FDA 510(k) clearance on 1977-08-04, under 510(k) number K771151.

Who is the listed applicant for ARTIUS SYSTEM?

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

What is the FDA product code for ARTIUS SYSTEM?

The FDA product code for ARTIUS SYSTEM is HGL.

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Related Devices (Code: HGL)

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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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