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FDA 510(k)

CONNEQT PULSE

K-Number: K221742 · 2023-04-21

ApplicantAtcor Medical
Decision Date2023-04-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONNEQT PULSE is the device name listed in this FDA 510(k) record. The listed applicant is Atcor Medical. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K221742. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONNEQT PULSE?

CONNEQT PULSE is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Atcor Medical. The 510(k) number is K221742.

When did CONNEQT PULSE receive FDA 510(k) clearance?

CONNEQT PULSE received FDA 510(k) clearance on 2023-04-21, under 510(k) number K221742.

Who is the listed applicant for CONNEQT PULSE?

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

What is the FDA product code for CONNEQT PULSE?

The FDA product code for CONNEQT PULSE is DXN.

Related Devices (Code: DXN)

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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