EasiSlush
K-Number: K191006 · 2019-09-24
ApplicantBridge TO Life, Ltd.
Decision Date2019-09-24
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
EasiSlush is a medical device manufactured by Bridge TO Life, Ltd.. It received FDA 510(k) clearance on 2019-09-24 under approval number K191006. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EasiSlush?
EasiSlush is a medical device that received FDA 510(k) clearance on 2019-09-24. It is manufactured by Bridge TO Life, Ltd.. The 510(k) number is K191006.
When was EasiSlush approved by the FDA?
EasiSlush received FDA 510(k) clearance on 2019-09-24, under approval number K191006.
What company makes EasiSlush?
EasiSlush is manufactured by Bridge TO Life, Ltd..
What is the FDA product code for EasiSlush?
The FDA product code for EasiSlush is KDN.
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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.