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FDA 510(k)

Patient Administration Set

K-Number: K200916 · 2020-09-01

ApplicantCyclomedica Australia Pty, Ltd.
Decision Date2020-09-01
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Patient Administration Set is a medical device manufactured by Cyclomedica Australia Pty, Ltd.. It received FDA 510(k) clearance on 2020-09-01 under approval number K200916. The device is classified under product code IYT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patient Administration Set?

Patient Administration Set is a medical device that received FDA 510(k) clearance on 2020-09-01. It is manufactured by Cyclomedica Australia Pty, Ltd.. The 510(k) number is K200916.

When was Patient Administration Set approved by the FDA?

Patient Administration Set received FDA 510(k) clearance on 2020-09-01, under approval number K200916.

What company makes Patient Administration Set?

Patient Administration Set is manufactured by Cyclomedica Australia Pty, Ltd..

What is the FDA product code for Patient Administration Set?

The FDA product code for Patient Administration Set is IYT.

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Related PubMed Literature

PMID: 41641793 Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making, 2016-2024. Clinical trials (London, England) (2026) PMID: 41265798 Comparison of two models of biofilm formation on reusable stainless steel medical device material. The Journal of hospital infection (2026) PMID: 40854178 Health Professional Students' Knowledge About FDA Drug and Medical Device Regulation. Academic medicine : journal of the Association of American Medical Colleges (2025) PMID: 40835433 Is the FDA regulation of cardiology AI devices supporting cardiovascular innovation: a scoping review. Heart (British Cardiac Society) (2026)

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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