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FDA 510(k)

BLESSING System

K-Number: K243176 · 2025-05-16

ApplicantCellah Medical Co., Ltd.
Decision Date2025-05-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BLESSING System is a medical device manufactured by Cellah Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-05-16 under approval number K243176. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLESSING System?

BLESSING System is a medical device that received FDA 510(k) clearance on 2025-05-16. It is manufactured by Cellah Medical Co., Ltd.. The 510(k) number is K243176.

When was BLESSING System approved by the FDA?

BLESSING System received FDA 510(k) clearance on 2025-05-16, under approval number K243176.

What company makes BLESSING System?

BLESSING System is manufactured by Cellah Medical Co., Ltd..

What is the FDA product code for BLESSING System?

The FDA product code for BLESSING System is GEI.

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Official Source

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