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FDA 510(k)

Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%

K-Number: K210126 · 2021-12-03

ApplicantThe Ritedose Corporation
Decision Date2021-12-03
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% is the device name listed in this FDA 510(k) record. The listed applicant is The Ritedose Corporation. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K210126. 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 Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%?

Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is The Ritedose Corporation. The 510(k) number is K210126.

When did Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% receive FDA 510(k) clearance?

Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% received FDA 510(k) clearance on 2021-12-03, under 510(k) number K210126.

Who is the listed applicant for Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%?

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

What is the FDA product code for Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%?

The FDA product code for Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% is CAF.

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Official Source

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