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FDA 510(k)

VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)

K-Number: K011625 · 2002-01-23

ApplicantVasocor, Inc.
Decision Date2002-01-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) is the device name listed in this FDA 510(k) record. The listed applicant is Vasocor, Inc.. It received FDA 510(k) clearance on 2002-01-23 under 510(k) number K011625. 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 VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)?

VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) is a medical device that received FDA 510(k) clearance on 2002-01-23. The listed applicant is Vasocor, Inc.. The 510(k) number is K011625.

When did VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) receive FDA 510(k) clearance?

VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) received FDA 510(k) clearance on 2002-01-23, under 510(k) number K011625.

Who is the listed applicant for VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)?

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

What is the FDA product code for VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)?

The FDA product code for VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) 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 Vasocor, 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.

K990123PVR-100/VASOGRAMK973659VASOCOR PVR 100

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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