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FDA 510(k)

INFUSION DYNAMICS POWER INFUSER

K-Number: K974074 · 1998-02-17

ApplicantInfusion Dynamics, Inc.
Decision Date1998-02-17
Product CodeKZD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSION DYNAMICS POWER INFUSER is the device name listed in this FDA 510(k) record. The listed applicant is Infusion Dynamics, Inc.. It received FDA 510(k) clearance on 1998-02-17 under 510(k) number K974074. 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 INFUSION DYNAMICS POWER INFUSER?

INFUSION DYNAMICS POWER INFUSER is a medical device that received FDA 510(k) clearance on 1998-02-17. The listed applicant is Infusion Dynamics, Inc.. The 510(k) number is K974074.

When did INFUSION DYNAMICS POWER INFUSER receive FDA 510(k) clearance?

INFUSION DYNAMICS POWER INFUSER received FDA 510(k) clearance on 1998-02-17, under 510(k) number K974074.

Who is the listed applicant for INFUSION DYNAMICS POWER INFUSER?

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

What is the FDA product code for INFUSION DYNAMICS POWER INFUSER?

The FDA product code for INFUSION DYNAMICS POWER INFUSER 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 Infusion Dynamics, 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.

K030739INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGEK992044INFUSION DYNAMICS POWER INFUSER MODEL M100B

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.

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.K921168ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000Allen Medical Systems, 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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