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FDA 510(k)

PROFILER 2

K-Number: K063021 · 2006-11-22

ApplicantSun Nuclear Corp.
Decision Date2006-11-22
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROFILER 2 is the device name listed in this FDA 510(k) record. The listed applicant is Sun Nuclear Corp.. It received FDA 510(k) clearance on 2006-11-22 under 510(k) number K063021. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFILER 2?

PROFILER 2 is a medical device that received FDA 510(k) clearance on 2006-11-22. The listed applicant is Sun Nuclear Corp.. The 510(k) number is K063021.

When did PROFILER 2 receive FDA 510(k) clearance?

PROFILER 2 received FDA 510(k) clearance on 2006-11-22, under 510(k) number K063021.

Who is the listed applicant for PROFILER 2?

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

What is the FDA product code for PROFILER 2?

The FDA product code for PROFILER 2 is IYE.

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Other records listing Sun Nuclear Corp. 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.

K112981SUN 125C IONIZATION CHAMBERK1019923D SCANNER, MODEL 1230K092019MODEL 1014 PC ELECTROMETERK051921THE EDGE DETECTOR, MODEL 1118K013689RE-ENTRANT CHAMBERK021463MODEL 1133 IVD PC VERSION

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Related Devices (Code: IYE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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