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FDA 510(k)

Basic, Dominant Flex

K-Number: K170329 · 2017-03-24

ApplicantModela AG
Decision Date2017-03-24
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Basic, Dominant Flex is a medical device manufactured by Modela AG. It received FDA 510(k) clearance on 2017-03-24 under approval number K170329. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Basic, Dominant Flex?

Basic, Dominant Flex is a medical device that received FDA 510(k) clearance on 2017-03-24. It is manufactured by Modela AG. The 510(k) number is K170329.

When was Basic, Dominant Flex approved by the FDA?

Basic, Dominant Flex received FDA 510(k) clearance on 2017-03-24, under approval number K170329.

What company makes Basic, Dominant Flex?

Basic, Dominant Flex is manufactured by Modela AG.

What is the FDA product code for Basic, Dominant Flex?

The FDA product code for Basic, Dominant Flex is QPB.

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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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