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FDA 510(k)

ELRAN 01 SYSTEM

K-Number: K002431 · 2000-10-24

ApplicantEnvision Advanced Medical System, Ltd.
Decision Date2000-10-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELRAN 01 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Envision Advanced Medical System, Ltd.. It received FDA 510(k) clearance on 2000-10-24 under 510(k) number K002431. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELRAN 01 SYSTEM?

ELRAN 01 SYSTEM is a medical device that received FDA 510(k) clearance on 2000-10-24. The listed applicant is Envision Advanced Medical System, Ltd.. The 510(k) number is K002431.

When did ELRAN 01 SYSTEM receive FDA 510(k) clearance?

ELRAN 01 SYSTEM received FDA 510(k) clearance on 2000-10-24, under 510(k) number K002431.

Who is the listed applicant for ELRAN 01 SYSTEM?

The FDA 510(k) record lists Envision Advanced Medical System, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELRAN 01 SYSTEM?

The FDA product code for ELRAN 01 SYSTEM is GCJ.

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Related Devices (Code: GCJ)

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

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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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