FirstSense Breast Exam— 510(k) K160573

Name: FDA 510(k) clearance K160573
Creator: U.S. Food and Drug Administration
Published: 2016-06-01

Substantially Equivalent

First Sense Medical, LLC

FDA 510(k) clearance K160573 for FirstSense Breast Exam, Substantially Equivalent on 2016-06-01. 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: 2016-02-29
Decision date: 2016-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pontiac, MI, 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.