Affinity
K-Number: K193152 · 2020-02-14
ApplicantHermes Medical Solutions AB
Decision Date2020-02-14
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Affinity is a medical device manufactured by Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2020-02-14 under approval number K193152. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Affinity?
Affinity is a medical device that received FDA 510(k) clearance on 2020-02-14. It is manufactured by Hermes Medical Solutions AB. The 510(k) number is K193152.
When was Affinity approved by the FDA?
Affinity received FDA 510(k) clearance on 2020-02-14, under approval number K193152.
What company makes Affinity?
Affinity is manufactured by Hermes Medical Solutions AB.
What is the FDA product code for Affinity?
The FDA product code for Affinity is KPS.
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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.