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FDA 510(k)

SPHYGMOCOR XCEL

K-Number: K122129 · 2012-11-16

ApplicantAtcor Medical
Decision Date2012-11-16
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPHYGMOCOR XCEL is the device name listed in this FDA 510(k) record. The listed applicant is Atcor Medical. It received FDA 510(k) clearance on 2012-11-16 under 510(k) number K122129. 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 SPHYGMOCOR XCEL?

SPHYGMOCOR XCEL is a medical device that received FDA 510(k) clearance on 2012-11-16. The listed applicant is Atcor Medical. The 510(k) number is K122129.

When did SPHYGMOCOR XCEL receive FDA 510(k) clearance?

SPHYGMOCOR XCEL received FDA 510(k) clearance on 2012-11-16, under 510(k) number K122129.

Who is the listed applicant for SPHYGMOCOR XCEL?

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 SPHYGMOCOR XCEL?

The FDA product code for SPHYGMOCOR XCEL is DXN.

Related Clinical Trials

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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Other records listing Atcor Medical 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.

K221742CONNEQT PULSEK080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

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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