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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 the device name listed in this FDA 510(k) record. The listed applicant is Mankind Pharma Limited. It received FDA 510(k) clearance on 2024-04-10 under 510(k) 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. The listed applicant is Mankind Pharma Limited. The 510(k) number is K232523.

When did Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% receive FDA 510(k) clearance?

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

Who is the listed applicant for Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%?

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

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

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