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FDA 510(k)

Cadwell AmpliScan

K-Number: K161027 · 2016-11-08

ApplicantCadwell Industries, Inc.
Decision Date2016-11-08
Product CodeOMA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cadwell AmpliScan is a medical device manufactured by Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2016-11-08 under approval number K161027. The device is classified under product code OMA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cadwell AmpliScan?

Cadwell AmpliScan is a medical device that received FDA 510(k) clearance on 2016-11-08. It is manufactured by Cadwell Industries, Inc.. The 510(k) number is K161027.

When was Cadwell AmpliScan approved by the FDA?

Cadwell AmpliScan received FDA 510(k) clearance on 2016-11-08, under approval number K161027.

What company makes Cadwell AmpliScan?

Cadwell AmpliScan is manufactured by Cadwell Industries, Inc..

What is the FDA product code for Cadwell AmpliScan?

The FDA product code for Cadwell AmpliScan is OMA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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