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FDA 510(k)

CytonPro-5000

K-Number: K213524 · 2022-08-10

ApplicantCytonsys, Inc.
Decision Date2022-08-10
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CytonPro-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Cytonsys, Inc.. It received FDA 510(k) clearance on 2022-08-10 under 510(k) number K213524. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CytonPro-5000?

CytonPro-5000 is a medical device that received FDA 510(k) clearance on 2022-08-10. The listed applicant is Cytonsys, Inc.. The 510(k) number is K213524.

When did CytonPro-5000 receive FDA 510(k) clearance?

CytonPro-5000 received FDA 510(k) clearance on 2022-08-10, under 510(k) number K213524.

Who is the listed applicant for CytonPro-5000?

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

What is the FDA product code for CytonPro-5000?

The FDA product code for CytonPro-5000 is ILY.

Related Devices (Code: ILY)

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.

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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.

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