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FDA 510(k)

SMOOV O10

K-Number: K192016 · 2020-05-19

ApplicantAlber GmbH
Decision Date2020-05-19
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SMOOV O10 is a medical device manufactured by Alber GmbH. It received FDA 510(k) clearance on 2020-05-19 under approval number K192016. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMOOV O10?

SMOOV O10 is a medical device that received FDA 510(k) clearance on 2020-05-19. It is manufactured by Alber GmbH. The 510(k) number is K192016.

When was SMOOV O10 approved by the FDA?

SMOOV O10 received FDA 510(k) clearance on 2020-05-19, under approval number K192016.

What company makes SMOOV O10?

SMOOV O10 is manufactured by Alber GmbH.

What is the FDA product code for SMOOV O10?

The FDA product code for SMOOV O10 is ITI.

Other Devices by Alber GmbH

K161241e-fix E35/E36 K151717twion K192618e-Motion M25 K221215e-motion M25

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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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