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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 the device name listed in this FDA 510(k) record. The listed applicant is Bomtech Electronics Co., Ltd.. It received FDA 510(k) clearance on 2024-12-26 under 510(k) 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. The listed applicant is Bomtech Electronics Co., Ltd.. The 510(k) number is K243097.

When did RM STAR EX with RMS Needle receive FDA 510(k) clearance?

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

Who is the listed applicant for RM STAR EX with RMS Needle?

The FDA 510(k) record lists Bomtech Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Bomtech Electronics Co., Ltd. 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.

K243143E-PEN (E-PEN)

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Official Source

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