Sentinel BreastScan II System— 510(k) K162767

Name: FDA 510(k) clearance K162767
Creator: U.S. Food and Drug Administration
Published: 2017-01-09

Substantially Equivalent

First Sense Medical, LLC

FDA 510(k) clearance K162767 for Sentinel BreastScan II System, Substantially Equivalent on 2017-01-09. Applicant: First Sense Medical, LLC. Device class: 1.

Clearance details

Applicant: First Sense Medical, LLC
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2016-09-30
Decision date: 2017-01-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Pontiac, MI, US

Download summary PDF View on FDA.gov ↗

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