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FDA 510(k)

Ortoma Treatment Solution - OTS

K-Number: K181449 · 2018-09-19

ApplicantOrtoma AB
Decision Date2018-09-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ortoma Treatment Solution - OTS is a medical device manufactured by Ortoma AB. It received FDA 510(k) clearance on 2018-09-19 under approval number K181449. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ortoma Treatment Solution - OTS?

Ortoma Treatment Solution - OTS is a medical device that received FDA 510(k) clearance on 2018-09-19. It is manufactured by Ortoma AB. The 510(k) number is K181449.

When was Ortoma Treatment Solution - OTS approved by the FDA?

Ortoma Treatment Solution - OTS received FDA 510(k) clearance on 2018-09-19, under approval number K181449.

What company makes Ortoma Treatment Solution - OTS?

Ortoma Treatment Solution - OTS is manufactured by Ortoma AB.

What is the FDA product code for Ortoma Treatment Solution - OTS?

The FDA product code for Ortoma Treatment Solution - OTS is OLO.

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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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