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FDA 510(k)

PADCHECK

K-Number: K093205 · 2010-04-01

ApplicantPadtest, LLC
Decision Date2010-04-01
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PADCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Padtest, LLC. It received FDA 510(k) clearance on 2010-04-01 under 510(k) number K093205. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PADCHECK?

PADCHECK is a medical device that received FDA 510(k) clearance on 2010-04-01. The listed applicant is Padtest, LLC. The 510(k) number is K093205.

When did PADCHECK receive FDA 510(k) clearance?

PADCHECK received FDA 510(k) clearance on 2010-04-01, under 510(k) number K093205.

Who is the listed applicant for PADCHECK?

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

What is the FDA product code for PADCHECK?

The FDA product code for PADCHECK is DXN.

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Related Devices (Code: DXN)

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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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