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FDA 510(k)

ADCOMP 4000 HP SYSTEM

K-Number: K874495 · 1988-02-16

ApplicantHealthtek, Inc.
Decision Date1988-02-16
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ADCOMP 4000 HP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Healthtek, Inc.. It received FDA 510(k) clearance on 1988-02-16 under 510(k) number K874495. 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 ADCOMP 4000 HP SYSTEM?

ADCOMP 4000 HP SYSTEM is a medical device that received FDA 510(k) clearance on 1988-02-16. The listed applicant is Healthtek, Inc.. The 510(k) number is K874495.

When did ADCOMP 4000 HP SYSTEM receive FDA 510(k) clearance?

ADCOMP 4000 HP SYSTEM received FDA 510(k) clearance on 1988-02-16, under 510(k) number K874495.

Who is the listed applicant for ADCOMP 4000 HP SYSTEM?

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

What is the FDA product code for ADCOMP 4000 HP SYSTEM?

The FDA product code for ADCOMP 4000 HP SYSTEM is LHI.

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Other records listing Healthtek, 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.

K923448EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEGK913985TRANSFER-AID(TM)K913608SNAPPERK881590ADFUSE(TM)K873848RETROBULBAR NEEDLEK860610ADCOMP

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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

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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