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FDA 510(k)

Ezvena IPC, Ezvena SQS

K-Number: K191937 · 2020-01-29

ApplicantEezcare Medical Corp
Decision Date2020-01-29
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ezvena IPC, Ezvena SQS is the device name listed in this FDA 510(k) record. The listed applicant is Eezcare Medical Corp. It received FDA 510(k) clearance on 2020-01-29 under 510(k) number K191937. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ezvena IPC, Ezvena SQS?

Ezvena IPC, Ezvena SQS is a medical device that received FDA 510(k) clearance on 2020-01-29. The listed applicant is Eezcare Medical Corp. The 510(k) number is K191937.

When did Ezvena IPC, Ezvena SQS receive FDA 510(k) clearance?

Ezvena IPC, Ezvena SQS received FDA 510(k) clearance on 2020-01-29, under 510(k) number K191937.

Who is the listed applicant for Ezvena IPC, Ezvena SQS?

The FDA 510(k) record lists Eezcare Medical Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ezvena IPC, Ezvena SQS?

The FDA product code for Ezvena IPC, Ezvena SQS is JOW.

Other records listing Eezcare Medical Corp as applicant

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.

K193662Ezlymph, Ezlymph M

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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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