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FDA 510(k)

Ballancer Platinum (1222)

K-Number: K230385 · 2023-04-04

ApplicantMego Afek
Decision Date2023-04-04
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Ballancer Platinum (1222) is a medical device manufactured by Mego Afek. It received FDA 510(k) clearance on 2023-04-04 under approval number K230385. 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 Platinum (1222)?

Ballancer Platinum (1222) is a medical device that received FDA 510(k) clearance on 2023-04-04. It is manufactured by Mego Afek. The 510(k) number is K230385.

When was Ballancer Platinum (1222) approved by the FDA?

Ballancer Platinum (1222) received FDA 510(k) clearance on 2023-04-04, under approval number K230385.

What company makes Ballancer Platinum (1222)?

Ballancer Platinum (1222) is manufactured by Mego Afek.

What is the FDA product code for Ballancer Platinum (1222)?

The FDA product code for Ballancer Platinum (1222) 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.

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