FDA 510(k)

ISIGHT

K-Number: K121519 · 2012-09-18

Decision Date2012-09-18

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

ISIGHT is the device name listed in this FDA 510(k) record. The listed applicant is C&E GP Specialists, Inc.. It received FDA 510(k) clearance on 2012-09-18 under 510(k) number K121519. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISIGHT?

ISIGHT is a medical device that received FDA 510(k) clearance on 2012-09-18. The listed applicant is C&E GP Specialists, Inc.. The 510(k) number is K121519.

When did ISIGHT receive FDA 510(k) clearance?

ISIGHT received FDA 510(k) clearance on 2012-09-18, under 510(k) number K121519.

Who is the listed applicant for ISIGHT?

The FDA 510(k) record lists C&E GP Specialists, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISIGHT?

The FDA product code for ISIGHT is LPL.

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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.