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FDA 510(k)

Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%

K-Number: K232523 · 2024-04-10

ApplicantMankind Pharma Limited
Decision Date2024-04-10
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% is a medical device manufactured by Mankind Pharma Limited. It received FDA 510(k) clearance on 2024-04-10 under approval number K232523. 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 Solution, USP 0.9%, 3% & 7%?

Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% is a medical device that received FDA 510(k) clearance on 2024-04-10. It is manufactured by Mankind Pharma Limited. The 510(k) number is K232523.

When was Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% approved by the FDA?

Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% received FDA 510(k) clearance on 2024-04-10, under approval number K232523.

What company makes Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%?

Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% is manufactured by Mankind Pharma Limited.

What is the FDA product code for Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%?

The FDA product code for Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% 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.

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