FDA 510(k)

AEROCURE-MD

K-Number: K203189 · 2021-01-21

Decision Date2021-01-21

Product CodeFRA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

AEROCURE-MD is the device name listed in this FDA 510(k) record. The listed applicant is Aerobiotix, Inc.. It received FDA 510(k) clearance on 2021-01-21 under 510(k) number K203189. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROCURE-MD?

AEROCURE-MD is a medical device that received FDA 510(k) clearance on 2021-01-21. The listed applicant is Aerobiotix, Inc.. The 510(k) number is K203189.

When did AEROCURE-MD receive FDA 510(k) clearance?

AEROCURE-MD received FDA 510(k) clearance on 2021-01-21, under 510(k) number K203189.

Who is the listed applicant for AEROCURE-MD?

The FDA 510(k) record lists Aerobiotix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AEROCURE-MD?

The FDA product code for AEROCURE-MD is FRA.

Related Devices (Code: FRA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.