MINISCAV
K-Number: K160950 · 2017-05-05
ApplicantSedation Systems, LLC
Decision Date2017-05-05
Product CodeCBN
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
MINISCAV is a medical device manufactured by Sedation Systems, LLC. It received FDA 510(k) clearance on 2017-05-05 under approval number K160950. The device is classified under product code CBN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MINISCAV?
MINISCAV is a medical device that received FDA 510(k) clearance on 2017-05-05. It is manufactured by Sedation Systems, LLC. The 510(k) number is K160950.
When was MINISCAV approved by the FDA?
MINISCAV received FDA 510(k) clearance on 2017-05-05, under approval number K160950.
What company makes MINISCAV?
MINISCAV is manufactured by Sedation Systems, LLC.
What is the FDA product code for MINISCAV?
The FDA product code for MINISCAV is CBN.
Related Devices (Code: CBN)
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.