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FDA 510(k)

ASCOT

K-Number: K132310 · 2013-12-23

ApplicantBackroads Consulting, Inc.
Decision Date2013-12-23
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASCOT is the device name listed in this FDA 510(k) record. The listed applicant is Backroads Consulting, Inc.. It received FDA 510(k) clearance on 2013-12-23 under 510(k) number K132310. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCOT?

ASCOT is a medical device that received FDA 510(k) clearance on 2013-12-23. The listed applicant is Backroads Consulting, Inc.. The 510(k) number is K132310.

When did ASCOT receive FDA 510(k) clearance?

ASCOT received FDA 510(k) clearance on 2013-12-23, under 510(k) number K132310.

Who is the listed applicant for ASCOT?

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

What is the FDA product code for ASCOT?

The FDA product code for ASCOT is KWQ.

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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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