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FDA 510(k)

DIMI RRT System

K-Number: K193005 · 2020-08-28

ApplicantDialco Medical, Inc.
Decision Date2020-08-28
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIMI RRT System is a medical device manufactured by Dialco Medical, Inc.. It received FDA 510(k) clearance on 2020-08-28 under approval number K193005. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMI RRT System?

DIMI RRT System is a medical device that received FDA 510(k) clearance on 2020-08-28. It is manufactured by Dialco Medical, Inc.. The 510(k) number is K193005.

When was DIMI RRT System approved by the FDA?

DIMI RRT System received FDA 510(k) clearance on 2020-08-28, under approval number K193005.

What company makes DIMI RRT System?

DIMI RRT System is manufactured by Dialco Medical, Inc..

What is the FDA product code for DIMI RRT System?

The FDA product code for DIMI RRT System is KDI.

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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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