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FDA 510(k)

AUTOMIX COMPOUNDER Y - ADAPTOR SET

K-Number: K890205 · 1989-10-27

ApplicantStedim, Inc.
Decision Date1989-10-27
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUTOMIX COMPOUNDER Y - ADAPTOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Stedim, Inc.. It received FDA 510(k) clearance on 1989-10-27 under 510(k) number K890205. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMIX COMPOUNDER Y - ADAPTOR SET?

AUTOMIX COMPOUNDER Y - ADAPTOR SET is a medical device that received FDA 510(k) clearance on 1989-10-27. The listed applicant is Stedim, Inc.. The 510(k) number is K890205.

When did AUTOMIX COMPOUNDER Y - ADAPTOR SET receive FDA 510(k) clearance?

AUTOMIX COMPOUNDER Y - ADAPTOR SET received FDA 510(k) clearance on 1989-10-27, under 510(k) number K890205.

Who is the listed applicant for AUTOMIX COMPOUNDER Y - ADAPTOR SET?

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

What is the FDA product code for AUTOMIX COMPOUNDER Y - ADAPTOR SET?

The FDA product code for AUTOMIX COMPOUNDER Y - ADAPTOR SET is LHI.

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 Stedim, 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.

K911567DUAL COMPARTMENT TPN BAG 3 LITERK890204AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR

Related Devices (Code: LHI)

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.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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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