OLINDA EXM
K-Number: K163687 · 2017-07-19
ApplicantHermes Medical Solutions AB
Decision Date2017-07-19
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OLINDA EXM is a medical device manufactured by Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2017-07-19 under approval number K163687. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OLINDA EXM?
OLINDA EXM is a medical device that received FDA 510(k) clearance on 2017-07-19. It is manufactured by Hermes Medical Solutions AB. The 510(k) number is K163687.
When was OLINDA EXM approved by the FDA?
OLINDA EXM received FDA 510(k) clearance on 2017-07-19, under approval number K163687.
What company makes OLINDA EXM?
OLINDA EXM is manufactured by Hermes Medical Solutions AB.
What is the FDA product code for OLINDA EXM?
The FDA product code for OLINDA EXM is IYX.
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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.