AEROCURE-MD— 510(k) K203189

Substantially Equivalent

Aerobiotix, Inc.

FDA 510(k) clearance K203189 for AEROCURE-MD, Substantially Equivalent on 2021-01-21. Applicant: Aerobiotix, Inc.. Device class: 2.

Clearance details

Applicant: Aerobiotix, Inc.
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2020-10-27
Decision date: 2021-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, 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.