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FDA 510(k)

Pro M Class

K-Number: K213897 · 2022-09-19

ApplicantSaeyang Microtech Co., Ltd.
Decision Date2022-09-19
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Pro M Class is a medical device manufactured by Saeyang Microtech Co., Ltd.. It received FDA 510(k) clearance on 2022-09-19 under approval number K213897. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pro M Class?

Pro M Class is a medical device that received FDA 510(k) clearance on 2022-09-19. It is manufactured by Saeyang Microtech Co., Ltd.. The 510(k) number is K213897.

When was Pro M Class approved by the FDA?

Pro M Class received FDA 510(k) clearance on 2022-09-19, under approval number K213897.

What company makes Pro M Class?

Pro M Class is manufactured by Saeyang Microtech Co., Ltd..

What is the FDA product code for Pro M Class?

The FDA product code for Pro M Class is EKX.

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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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