Wrap accessory electrodes
K-Number: K190617 · 2019-07-02
ApplicantHi-Dow International, Inc.
Decision Date2019-07-02
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Wrap accessory electrodes is a medical device manufactured by Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2019-07-02 under approval number K190617. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Wrap accessory electrodes?
Wrap accessory electrodes is a medical device that received FDA 510(k) clearance on 2019-07-02. It is manufactured by Hi-Dow International, Inc.. The 510(k) number is K190617.
When was Wrap accessory electrodes approved by the FDA?
Wrap accessory electrodes received FDA 510(k) clearance on 2019-07-02, under approval number K190617.
What company makes Wrap accessory electrodes?
Wrap accessory electrodes is manufactured by Hi-Dow International, Inc..
What is the FDA product code for Wrap accessory electrodes?
The FDA product code for Wrap accessory electrodes is GXY.
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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.