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FDA 510(k)

Breezeway II

K-Number: K210627 · 2021-06-03

ApplicantOscor, Inc.
Decision Date2021-06-03
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Breezeway II is a medical device manufactured by Oscor, Inc.. It received FDA 510(k) clearance on 2021-06-03 under approval number K210627. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Breezeway II?

Breezeway II is a medical device that received FDA 510(k) clearance on 2021-06-03. It is manufactured by Oscor, Inc.. The 510(k) number is K210627.

When was Breezeway II approved by the FDA?

Breezeway II received FDA 510(k) clearance on 2021-06-03, under approval number K210627.

What company makes Breezeway II?

Breezeway II is manufactured by Oscor, Inc..

What is the FDA product code for Breezeway II?

The FDA product code for Breezeway II is DYB.

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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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