Maxima Electric System
K-Number: K180845 · 2019-07-25
ApplicantHandpiece Headquarters - Hpr, Inc.
Decision Date2019-07-25
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Maxima Electric System is a medical device manufactured by Handpiece Headquarters - Hpr, Inc.. It received FDA 510(k) clearance on 2019-07-25 under approval number K180845. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Maxima Electric System?
Maxima Electric System is a medical device that received FDA 510(k) clearance on 2019-07-25. It is manufactured by Handpiece Headquarters - Hpr, Inc.. The 510(k) number is K180845.
When was Maxima Electric System approved by the FDA?
Maxima Electric System received FDA 510(k) clearance on 2019-07-25, under approval number K180845.
What company makes Maxima Electric System?
Maxima Electric System is manufactured by Handpiece Headquarters - Hpr, Inc..
What is the FDA product code for Maxima Electric System?
The FDA product code for Maxima Electric System is EBW.
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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.