MediClear PreOp
K-Number: K163556 · 2017-09-14
ApplicantCovalontechnologies, Inc.
Decision Date2017-09-14
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
MediClear PreOp is a medical device manufactured by Covalontechnologies, Inc.. It received FDA 510(k) clearance on 2017-09-14 under approval number K163556. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MediClear PreOp?
MediClear PreOp is a medical device that received FDA 510(k) clearance on 2017-09-14. It is manufactured by Covalontechnologies, Inc.. The 510(k) number is K163556.
When was MediClear PreOp approved by the FDA?
MediClear PreOp received FDA 510(k) clearance on 2017-09-14, under approval number K163556.
What company makes MediClear PreOp?
MediClear PreOp is manufactured by Covalontechnologies, Inc..
What is the FDA product code for MediClear PreOp?
The FDA product code for MediClear PreOp is KKX.
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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.