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FDA 510(k)

Vario 8/18/ci

K-Number: K153663 · 2016-05-18

ApplicantMedela AG
Decision Date2016-05-18
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Vario 8/18/ci is a medical device manufactured by Medela AG. It received FDA 510(k) clearance on 2016-05-18 under approval number K153663. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vario 8/18/ci?

Vario 8/18/ci is a medical device that received FDA 510(k) clearance on 2016-05-18. It is manufactured by Medela AG. The 510(k) number is K153663.

When was Vario 8/18/ci approved by the FDA?

Vario 8/18/ci received FDA 510(k) clearance on 2016-05-18, under approval number K153663.

What company makes Vario 8/18/ci?

Vario 8/18/ci is manufactured by Medela AG.

What is the FDA product code for Vario 8/18/ci?

The FDA product code for Vario 8/18/ci is BTA.

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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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