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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 the device name listed in this FDA 510(k) record. The listed applicant is Dimar S.P.A.. It received FDA 510(k) clearance on 2024-08-14 under 510(k) 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. The listed applicant is Dimar S.P.A.. The 510(k) number is K232836.

When did Family of DIMAR DMAX NIV masks receive FDA 510(k) clearance?

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

Who is the listed applicant for Family of DIMAR DMAX NIV masks?

The FDA 510(k) record lists Dimar S.P.A. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: CBK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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