Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Z-LINKPC System

K-Number: K211993 · 2021-08-11

Decision Date2021-08-11
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Z-LINKPC System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2021-08-11 under approval 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. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K211993.

When was Z-LINKPC System approved by the FDA?

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

What company makes Z-LINKPC System?

Z-LINKPC System is manufactured by Zavation Medical Products, LLC.

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

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

Other Devices by Zavation Medical Products, LLC

View all 30 devices →

Related Devices (Code: NKG)

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.