Ballancer Gold, 1212
K-Number: K190015 · 2019-03-25
ApplicantMego Afek AC , Ltd.
Decision Date2019-03-25
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Ballancer Gold, 1212 is a medical device manufactured by Mego Afek AC , Ltd.. It received FDA 510(k) clearance on 2019-03-25 under approval number K190015. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ballancer Gold, 1212?
Ballancer Gold, 1212 is a medical device that received FDA 510(k) clearance on 2019-03-25. It is manufactured by Mego Afek AC , Ltd.. The 510(k) number is K190015.
When was Ballancer Gold, 1212 approved by the FDA?
Ballancer Gold, 1212 received FDA 510(k) clearance on 2019-03-25, under approval number K190015.
What company makes Ballancer Gold, 1212?
Ballancer Gold, 1212 is manufactured by Mego Afek AC , Ltd..
What is the FDA product code for Ballancer Gold, 1212?
The FDA product code for Ballancer Gold, 1212 is IRP.
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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.