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FDA 510(k)

PrevisEA Device

K-Number: K211068 · 2021-08-04

ApplicantEntac Medical, Inc.
Decision Date2021-08-04
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PrevisEA Device is the device name listed in this FDA 510(k) record. The listed applicant is Entac Medical, Inc.. It received FDA 510(k) clearance on 2021-08-04 under 510(k) number K211068. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PrevisEA Device?

PrevisEA Device is a medical device that received FDA 510(k) clearance on 2021-08-04. The listed applicant is Entac Medical, Inc.. The 510(k) number is K211068.

When did PrevisEA Device receive FDA 510(k) clearance?

PrevisEA Device received FDA 510(k) clearance on 2021-08-04, under 510(k) number K211068.

Who is the listed applicant for PrevisEA Device?

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

What is the FDA product code for PrevisEA Device?

The FDA product code for PrevisEA Device is DQD.

Other records listing Entac Medical, Inc. 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.

K230769PrevisEA Device

Related Devices (Code: DQD)

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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