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FDA 510(k)

OTS 25-L (100-5)

K-Number: K241234 · 2025-01-23

ApplicantOts Medical , Ltd.
Decision Date2025-01-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OTS 25-L (100-5) is a medical device manufactured by Ots Medical , Ltd.. It received FDA 510(k) clearance on 2025-01-23 under approval number K241234. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTS 25-L (100-5)?

OTS 25-L (100-5) is a medical device that received FDA 510(k) clearance on 2025-01-23. It is manufactured by Ots Medical , Ltd.. The 510(k) number is K241234.

When was OTS 25-L (100-5) approved by the FDA?

OTS 25-L (100-5) received FDA 510(k) clearance on 2025-01-23, under approval number K241234.

What company makes OTS 25-L (100-5)?

OTS 25-L (100-5) is manufactured by Ots Medical , Ltd..

What is the FDA product code for OTS 25-L (100-5)?

The FDA product code for OTS 25-L (100-5) is MBI.

Other Devices by Ots Medical , Ltd.

K233429OTS 25 (100-1) K251310OTS 25-L (100-5)

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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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