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FDA 510(k)

ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000

K-Number: K921168 · 1993-04-21

ApplicantAllen Medical Systems, Inc.
Decision Date1993-04-21
Product CodeKZD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Allen Medical Systems, Inc.. It received FDA 510(k) clearance on 1993-04-21 under 510(k) number K921168. The device is classified under product code KZD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000?

ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 is a medical device that received FDA 510(k) clearance on 1993-04-21. The listed applicant is Allen Medical Systems, Inc.. The 510(k) number is K921168.

When did ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 receive FDA 510(k) clearance?

ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 received FDA 510(k) clearance on 1993-04-21, under 510(k) number K921168.

Who is the listed applicant for ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000?

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

What is the FDA product code for ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000?

The FDA product code for ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 is KZD.

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 Allen Medical Systems, 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.

K971988ALLEN, ULTRA AND SMART SOCKETSK964273DURA-BOARD ARMBOARDK960027HIGH VOLUME I.V. & IRRIGATION TOWERK944779CARBON LIGHTS HAND SURGERY TABLE

Related Devices (Code: KZD)

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.

K974074INFUSION DYNAMICS POWER INFUSERInfusion Dynamics, Inc.K973843MSI PRESSURE INFUSORSmith Assoc.K953290OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMPOlympus America, Inc.K951988PRESSURIZERPromedic, Inc.K942933PRESSURE INFUSION CUFFCirculatory Technology, Inc.K930012KAWASUMI LABORATORIES K-CUFFKawasumi Laboratories Co., Ltd.

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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