Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)— 510(k) K230734

Name: FDA 510(k) clearance K230734
Creator: U.S. Food and Drug Administration
Published: 2023-12-05

Substantially Equivalent

Precision Healing, LLC

FDA 510(k) clearance K230734 for Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009), Substantially Equivalent on 2023-12-05. Applicant: Precision Healing, LLC. Device class: 2.

Clearance details

Applicant: Precision Healing, LLC
Product code: Code QJF
Device class: Class 2
Regulation: 21 CFR 878.4550
Advisory panel: General, Plastic Surgery
Date received: 2023-03-16
Decision date: 2023-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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