Adena-Zina System
K-Number: K212066 · 2021-08-16
ApplicantShanghai Sanyou Medical Co, Ltd.
Decision Date2021-08-16
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Adena-Zina System is a medical device manufactured by Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2021-08-16 under approval number K212066. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Adena-Zina System?
Adena-Zina System is a medical device that received FDA 510(k) clearance on 2021-08-16. It is manufactured by Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K212066.
When was Adena-Zina System approved by the FDA?
Adena-Zina System received FDA 510(k) clearance on 2021-08-16, under approval number K212066.
What company makes Adena-Zina System?
Adena-Zina System is manufactured by Shanghai Sanyou Medical Co, Ltd..
What is the FDA product code for Adena-Zina System?
The FDA product code for Adena-Zina System is NKB.
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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.