Ballancer Platinum (1222)
K-Number: K230385 · 2023-04-04
Device Summary
Frequently Asked Questions
What is the Ballancer Platinum (1222)?
Ballancer Platinum (1222) is a medical device that received FDA 510(k) clearance on 2023-04-04. The listed applicant is Mego Afek. The 510(k) number is K230385.
When did Ballancer Platinum (1222) receive FDA 510(k) clearance?
Ballancer Platinum (1222) received FDA 510(k) clearance on 2023-04-04, under 510(k) number K230385.
Who is the listed applicant for Ballancer Platinum (1222)?
The FDA 510(k) record lists Mego Afek as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ballancer Platinum (1222)?
The FDA product code for Ballancer Platinum (1222) is IRP.
Other records listing Mego Afek 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.