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FDA 510(k)

MOVIX DReamy

K-Number: K212515 · 2021-11-03

ApplicantStephanix
Decision Date2021-11-03
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOVIX DReamy is a medical device manufactured by Stephanix. It received FDA 510(k) clearance on 2021-11-03 under approval number K212515. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOVIX DReamy?

MOVIX DReamy is a medical device that received FDA 510(k) clearance on 2021-11-03. It is manufactured by Stephanix. The 510(k) number is K212515.

When was MOVIX DReamy approved by the FDA?

MOVIX DReamy received FDA 510(k) clearance on 2021-11-03, under approval number K212515.

What company makes MOVIX DReamy?

MOVIX DReamy is manufactured by Stephanix.

What is the FDA product code for MOVIX DReamy?

The FDA product code for MOVIX DReamy is IZL.

Other Devices by Stephanix

K213479D²RS and D²RS 9090 K221335D²RS and D²RS 9090

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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