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FDA 510(k)

SPHYGMOCOR PX MODEL SCOR-PX

K-Number: K012487 · 2002-02-21

ApplicantAtcor Medical Pty, Ltd.
Decision Date2002-02-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPHYGMOCOR PX MODEL SCOR-PX is the device name listed in this FDA 510(k) record. The listed applicant is Atcor Medical Pty, Ltd.. It received FDA 510(k) clearance on 2002-02-21 under 510(k) number K012487. 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 PX MODEL SCOR-PX?

SPHYGMOCOR PX MODEL SCOR-PX is a medical device that received FDA 510(k) clearance on 2002-02-21. The listed applicant is Atcor Medical Pty, Ltd.. The 510(k) number is K012487.

When did SPHYGMOCOR PX MODEL SCOR-PX receive FDA 510(k) clearance?

SPHYGMOCOR PX MODEL SCOR-PX received FDA 510(k) clearance on 2002-02-21, under 510(k) number K012487.

Who is the listed applicant for SPHYGMOCOR PX MODEL SCOR-PX?

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

What is the FDA product code for SPHYGMOCOR PX MODEL SCOR-PX?

The FDA product code for SPHYGMOCOR PX MODEL SCOR-PX 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 Pty, Ltd. 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.

K070795SPHYGMOCOR 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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