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FDA 510(k)

AEROCURE-MD

K-Number: K203189 · 2021-01-21

ApplicantAerobiotix, Inc.
Decision Date2021-01-21
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AEROCURE-MD is a medical device manufactured by Aerobiotix, Inc.. It received FDA 510(k) clearance on 2021-01-21 under approval 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. It is manufactured by Aerobiotix, Inc.. The 510(k) number is K203189.

When was AEROCURE-MD approved by the FDA?

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

What company makes AEROCURE-MD?

AEROCURE-MD is manufactured by Aerobiotix, Inc..

What is the FDA product code for AEROCURE-MD?

The FDA product code for AEROCURE-MD is FRA.

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Official Source

View on FDA Database →

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

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