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FDA 510(k)

GS-128 GRADIENT COMPRESSION SYSTEM

K-Number: K050584 · 2005-03-22

ApplicantMedmark Technologies, LLC
Decision Date2005-03-22
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GS-128 GRADIENT COMPRESSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medmark Technologies, LLC. It received FDA 510(k) clearance on 2005-03-22 under 510(k) number K050584. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GS-128 GRADIENT COMPRESSION SYSTEM?

GS-128 GRADIENT COMPRESSION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-03-22. The listed applicant is Medmark Technologies, LLC. The 510(k) number is K050584.

When did GS-128 GRADIENT COMPRESSION SYSTEM receive FDA 510(k) clearance?

GS-128 GRADIENT COMPRESSION SYSTEM received FDA 510(k) clearance on 2005-03-22, under 510(k) number K050584.

Who is the listed applicant for GS-128 GRADIENT COMPRESSION SYSTEM?

The FDA 510(k) record lists Medmark Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GS-128 GRADIENT COMPRESSION SYSTEM?

The FDA product code for GS-128 GRADIENT COMPRESSION SYSTEM is JOW.

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Related Devices (Code: JOW)

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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