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FDA 510(k)

Z-LINKPC System

K-Number: K211993 · 2021-08-11

ApplicantZavation Medical Products, LLC
Decision Date2021-08-11
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Z-LINKPC System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2021-08-11 under 510(k) number K211993. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z-LINKPC System?

Z-LINKPC System is a medical device that received FDA 510(k) clearance on 2021-08-11. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K211993.

When did Z-LINKPC System receive FDA 510(k) clearance?

Z-LINKPC System received FDA 510(k) clearance on 2021-08-11, under 510(k) number K211993.

Who is the listed applicant for Z-LINKPC System?

The FDA 510(k) record lists Zavation Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Z-LINKPC System?

The FDA product code for Z-LINKPC System is NKG.

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Related Devices (Code: NKG)

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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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