FDA 510(k)

LOWTEM Crystal 120

K-Number: K231893 · 2024-09-18

Decision Date2024-09-18

Product CodeMLR

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LOWTEM Crystal 120 is a medical device manufactured by Lowtem Co., Ltd.. It received FDA 510(k) clearance on 2024-09-18 under approval number K231893. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOWTEM Crystal 120?

LOWTEM Crystal 120 is a medical device that received FDA 510(k) clearance on 2024-09-18. It is manufactured by Lowtem Co., Ltd.. The 510(k) number is K231893.

When was LOWTEM Crystal 120 approved by the FDA?

LOWTEM Crystal 120 received FDA 510(k) clearance on 2024-09-18, under approval number K231893.

What company makes LOWTEM Crystal 120?

LOWTEM Crystal 120 is manufactured by Lowtem Co., Ltd..

What is the FDA product code for LOWTEM Crystal 120?

The FDA product code for LOWTEM Crystal 120 is MLR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.