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FDA 510(k)

OTS 25 (100-1)

K-Number: K233429 · 2023-12-07

ApplicantOts Medical , Ltd.
Decision Date2023-12-07
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OTS 25 (100-1) is a medical device manufactured by Ots Medical , Ltd.. It received FDA 510(k) clearance on 2023-12-07 under approval number K233429. 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 (100-1)?

OTS 25 (100-1) is a medical device that received FDA 510(k) clearance on 2023-12-07. It is manufactured by Ots Medical , Ltd.. The 510(k) number is K233429.

When was OTS 25 (100-1) approved by the FDA?

OTS 25 (100-1) received FDA 510(k) clearance on 2023-12-07, under approval number K233429.

What company makes OTS 25 (100-1)?

OTS 25 (100-1) is manufactured by Ots Medical , Ltd..

What is the FDA product code for OTS 25 (100-1)?

The FDA product code for OTS 25 (100-1) is MBI.

Other Devices by Ots Medical , Ltd.

K251310OTS 25-L (100-5) K241234OTS 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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