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 a medical device manufactured by The Ritedose Corporation. It received FDA 510(k) clearance on 2021-12-03 under approval 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. It is manufactured by The Ritedose Corporation. The 510(k) number is K210126.
When was Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% approved by the FDA?
Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% received FDA 510(k) clearance on 2021-12-03, under approval number K210126.
What company makes Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%?
Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% is manufactured by The Ritedose Corporation.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.