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FDA 510(k)

IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT

K-Number: K961486 · 1998-04-17

ApplicantIvac Medical Systems
Decision Date1998-04-17
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ivac Medical Systems. It received FDA 510(k) clearance on 1998-04-17 under 510(k) number K961486. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT?

IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT is a medical device that received FDA 510(k) clearance on 1998-04-17. The listed applicant is Ivac Medical Systems. The 510(k) number is K961486.

When did IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT receive FDA 510(k) clearance?

IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT received FDA 510(k) clearance on 1998-04-17, under 510(k) number K961486.

Who is the listed applicant for IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT?

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

What is the FDA product code for IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT?

The FDA product code for IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT is MRZ.

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 Ivac Medical Systems 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.

K970485SMARTSITE ACCESS PIN

Related Devices (Code: MRZ)

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.

K230718UTC 3mL Medication CartridgeGilero, LLCK220695Elite Biomedical Solutions Dose Request CordElite Biomedical SolutionsK201634RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd.K193654BlueStar RxWelldoc, Inc.K191910SpaceStation MRIB. Braun Melsugen AGK190013WellDoc BlueStarWelldoc, Inc.

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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