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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 the device name listed in this FDA 510(k) record. The listed applicant is Protomed, Inc.. It received FDA 510(k) clearance on 2020-11-04 under 510(k) 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. The listed applicant is Protomed, Inc.. The 510(k) number is K193499.

When did DigiGuide System receive FDA 510(k) clearance?

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

Who is the listed applicant for DigiGuide System?

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

What is the FDA product code for DigiGuide System?

The FDA product code for DigiGuide System is DZJ.

Related Devices (Code: DZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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