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FDA 510(k)

Family of DIMAR DMAX NIV masks

K-Number: K232836 · 2024-08-14

ApplicantDimar S.P.A.
Decision Date2024-08-14
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Family of DIMAR DMAX NIV masks is a medical device manufactured by Dimar S.P.A.. It received FDA 510(k) clearance on 2024-08-14 under approval number K232836. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Family of DIMAR DMAX NIV masks?

Family of DIMAR DMAX NIV masks is a medical device that received FDA 510(k) clearance on 2024-08-14. It is manufactured by Dimar S.P.A.. The 510(k) number is K232836.

When was Family of DIMAR DMAX NIV masks approved by the FDA?

Family of DIMAR DMAX NIV masks received FDA 510(k) clearance on 2024-08-14, under approval number K232836.

What company makes Family of DIMAR DMAX NIV masks?

Family of DIMAR DMAX NIV masks is manufactured by Dimar S.P.A..

What is the FDA product code for Family of DIMAR DMAX NIV masks?

The FDA product code for Family of DIMAR DMAX NIV masks is CBK.

Related Clinical Trials

Related Devices (Code: CBK)

Official Source

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