Ballancer Gold, 1212
K-Number: K190015 · 2019-03-25
Device Summary
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. The listed applicant is Mego Afek AC , Ltd.. The 510(k) number is K190015.
When did Ballancer Gold, 1212 receive FDA 510(k) clearance?
Ballancer Gold, 1212 received FDA 510(k) clearance on 2019-03-25, under 510(k) number K190015.
Who is the listed applicant for Ballancer Gold, 1212?
The FDA 510(k) record lists Mego Afek AC , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ballancer Gold, 1212?
The FDA product code for Ballancer Gold, 1212 is IRP.
Other records listing Mego Afek AC , Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: IRP)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.