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FDA 510(k)

FUTREX-5000A

K-Number: K922601 · 1995-12-28

ApplicantFutrex, Inc.
Decision Date1995-12-28
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUTREX-5000A is the device name listed in this FDA 510(k) record. The listed applicant is Futrex, Inc.. It received FDA 510(k) clearance on 1995-12-28 under 510(k) number K922601. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUTREX-5000A?

FUTREX-5000A is a medical device that received FDA 510(k) clearance on 1995-12-28. The listed applicant is Futrex, Inc.. The 510(k) number is K922601.

When did FUTREX-5000A receive FDA 510(k) clearance?

FUTREX-5000A received FDA 510(k) clearance on 1995-12-28, under 510(k) number K922601.

Who is the listed applicant for FUTREX-5000A?

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

What is the FDA product code for FUTREX-5000A?

The FDA product code for FUTREX-5000A is DSB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Futrex, Inc. 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.

K963271FUTREX-6100/XLK922600FUTREX-5000

Related Devices (Code: DSB)

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.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.

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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