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FDA 510(k)

RM STAR EX with RMS Needle

K-Number: K243097 · 2024-12-26

ApplicantBomtech Electronics Co., Ltd.
Decision Date2024-12-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RM STAR EX with RMS Needle is a medical device manufactured by Bomtech Electronics Co., Ltd.. It received FDA 510(k) clearance on 2024-12-26 under approval number K243097. 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 RM STAR EX with RMS Needle?

RM STAR EX with RMS Needle is a medical device that received FDA 510(k) clearance on 2024-12-26. It is manufactured by Bomtech Electronics Co., Ltd.. The 510(k) number is K243097.

When was RM STAR EX with RMS Needle approved by the FDA?

RM STAR EX with RMS Needle received FDA 510(k) clearance on 2024-12-26, under approval number K243097.

What company makes RM STAR EX with RMS Needle?

RM STAR EX with RMS Needle is manufactured by Bomtech Electronics Co., Ltd..

What is the FDA product code for RM STAR EX with RMS Needle?

The FDA product code for RM STAR EX with RMS Needle is GEI.

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Official Source

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