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FDA 510(k)

DigiGuide System

K-Number: K193499 · 2020-11-04

ApplicantProtomed, Inc.
Decision Date2020-11-04
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DigiGuide System is a medical device manufactured by Protomed, Inc.. It received FDA 510(k) clearance on 2020-11-04 under approval number K193499. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DigiGuide System?

DigiGuide System is a medical device that received FDA 510(k) clearance on 2020-11-04. It is manufactured by Protomed, Inc.. The 510(k) number is K193499.

When was DigiGuide System approved by the FDA?

DigiGuide System received FDA 510(k) clearance on 2020-11-04, under approval number K193499.

What company makes DigiGuide System?

DigiGuide System is manufactured by Protomed, Inc..

What is the FDA product code for DigiGuide System?

The FDA product code for DigiGuide System is DZJ.

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Official Source

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