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FDA 510(k)

E4D COMPASS

K-Number: K110511 · 2011-03-11

ApplicantD4D Technologies
Decision Date2011-03-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

E4D COMPASS is the device name listed in this FDA 510(k) record. The listed applicant is D4D Technologies. It received FDA 510(k) clearance on 2011-03-11 under 510(k) number K110511. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E4D COMPASS?

E4D COMPASS is a medical device that received FDA 510(k) clearance on 2011-03-11. The listed applicant is D4D Technologies. The 510(k) number is K110511.

When did E4D COMPASS receive FDA 510(k) clearance?

E4D COMPASS received FDA 510(k) clearance on 2011-03-11, under 510(k) number K110511.

Who is the listed applicant for E4D COMPASS?

The FDA 510(k) record lists D4D Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E4D COMPASS?

The FDA product code for E4D COMPASS is LLZ.

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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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