Neocis Planning Software Application (NPSA) for 3rd Party PCs— 510(k) K191363

Name: FDA 510(k) clearance K191363
Creator: U.S. Food and Drug Administration
Published: 2019-10-02

Substantially Equivalent

Neocis, Inc.

FDA 510(k) clearance K191363 for Neocis Planning Software Application (NPSA) for 3rd Party PCs, Substantially Equivalent on 2019-10-02. Applicant: Neocis, Inc.. Device class: 2.

Clearance details

Applicant: Neocis, Inc.
Product code: Code PLV
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2019-05-22
Decision date: 2019-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.