ABSOLU
K-Number: K183414 · 2019-03-20
ApplicantQuantel Medical
Decision Date2019-03-20
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ABSOLU is a medical device manufactured by Quantel Medical. It received FDA 510(k) clearance on 2019-03-20 under approval number K183414. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ABSOLU?
ABSOLU is a medical device that received FDA 510(k) clearance on 2019-03-20. It is manufactured by Quantel Medical. The 510(k) number is K183414.
When was ABSOLU approved by the FDA?
ABSOLU received FDA 510(k) clearance on 2019-03-20, under approval number K183414.
What company makes ABSOLU?
ABSOLU is manufactured by Quantel Medical.
What is the FDA product code for ABSOLU?
The FDA product code for ABSOLU is IYO.
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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.