FDA 510(k)

THE EDGE DETECTOR, MODEL 1118

K-Number: K051921 · 2005-07-27

Decision Date2005-07-27

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

THE EDGE DETECTOR, MODEL 1118 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 2005-07-27 under 510(k) number K051921. 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 THE EDGE DETECTOR, MODEL 1118?

THE EDGE DETECTOR, MODEL 1118 is a medical device that received FDA 510(k) clearance on 2005-07-27. The listed applicant is Sun Nuclear Corp.. The 510(k) number is K051921.

When did THE EDGE DETECTOR, MODEL 1118 receive FDA 510(k) clearance?

THE EDGE DETECTOR, MODEL 1118 received FDA 510(k) clearance on 2005-07-27, under 510(k) number K051921.

Who is the listed applicant for THE EDGE DETECTOR, MODEL 1118?

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 THE EDGE DETECTOR, MODEL 1118?

The FDA product code for THE EDGE DETECTOR, MODEL 1118 is IYE.

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Other records listing Sun Nuclear Corp. as applicant

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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.