Aegis Transit System— 510(k) K170757

Name: FDA 510(k) clearance K170757
Creator: U.S. Food and Drug Administration
Published: 2017-07-14

Substantially Equivalent

Boston-Biomedical Associates

FDA 510(k) clearance K170757 for Aegis Transit System, Substantially Equivalent on 2017-07-14. Applicant: Boston-Biomedical Associates. Device class: 2.

Clearance details

Applicant: Boston-Biomedical Associates
Product code: Code EWY
Device class: Class 2
Regulation: 21 CFR 874.4720
Advisory panel: Ear, Nose, Throat
Date received: 2017-03-13
Decision date: 2017-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malborough, MA, 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.