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FDA 510(k)

A SCOPE

K-Number: K103499 · 2011-03-31

ApplicantActive Signal Technologies, Inc.
Decision Date2011-03-31
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

A SCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Active Signal Technologies, Inc.. It received FDA 510(k) clearance on 2011-03-31 under 510(k) number K103499. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A SCOPE?

A SCOPE is a medical device that received FDA 510(k) clearance on 2011-03-31. The listed applicant is Active Signal Technologies, Inc.. The 510(k) number is K103499.

When did A SCOPE receive FDA 510(k) clearance?

A SCOPE received FDA 510(k) clearance on 2011-03-31, under 510(k) number K103499.

Who is the listed applicant for A SCOPE?

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

What is the FDA product code for A SCOPE?

The FDA product code for A SCOPE is DQD.

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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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