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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 the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 2021-06-03 under 510(k) 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. The listed applicant is Oscor, Inc.. The 510(k) number is K210627.

When did Breezeway II receive FDA 510(k) clearance?

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

Who is the listed applicant for Breezeway II?

The FDA 510(k) record lists Oscor, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Breezeway II?

The FDA product code for Breezeway II is DYB.

Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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