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FDA 510(k)

Vapotherm Aerosol Adapter AAA-2

K-Number: K220869 · 2022-10-28

ApplicantVapotherm, Inc.
Decision Date2022-10-28
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Vapotherm Aerosol Adapter AAA-2 is the device name listed in this FDA 510(k) record. The listed applicant is Vapotherm, Inc.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K220869. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vapotherm Aerosol Adapter AAA-2?

Vapotherm Aerosol Adapter AAA-2 is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Vapotherm, Inc.. The 510(k) number is K220869.

When did Vapotherm Aerosol Adapter AAA-2 receive FDA 510(k) clearance?

Vapotherm Aerosol Adapter AAA-2 received FDA 510(k) clearance on 2022-10-28, under 510(k) number K220869.

Who is the listed applicant for Vapotherm Aerosol Adapter AAA-2?

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

What is the FDA product code for Vapotherm Aerosol Adapter AAA-2?

The FDA product code for Vapotherm Aerosol Adapter AAA-2 is CAF.

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Official Source

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