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 the device name listed in this FDA 510(k) record. The listed applicant is Cyclomedica Australia Pty, Ltd.. It received FDA 510(k) clearance on 2020-09-01 under 510(k) 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. The listed applicant is Cyclomedica Australia Pty, Ltd.. The 510(k) number is K200916.

When did Patient Administration Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Patient Administration Set?

The FDA 510(k) record lists Cyclomedica Australia Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Patient Administration Set?

The FDA product code for Patient Administration Set is IYT.

Related Devices (Code: IYT)

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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.