DigiGuide System— 510(k) K193499

Substantially Equivalent

Protomed, Inc.

FDA 510(k) clearance K193499 for DigiGuide System, Substantially Equivalent on 2020-11-04. Applicant: Protomed, Inc.. Device class: 2.

Clearance details

Applicant: Protomed, Inc.
Product code: Code DZJ
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2019-12-17
Decision date: 2020-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminster, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.