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FDA 510(k)

Besmed Bacterial Filter and HMEF

K-Number: K241339 · 2024-11-14

ApplicantBesmed Health Business Corp
Decision Date2024-11-14
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Besmed Bacterial Filter and HMEF is the device name listed in this FDA 510(k) record. The listed applicant is Besmed Health Business Corp. It received FDA 510(k) clearance on 2024-11-14 under 510(k) number K241339. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Besmed Bacterial Filter and HMEF?

Besmed Bacterial Filter and HMEF is a medical device that received FDA 510(k) clearance on 2024-11-14. The listed applicant is Besmed Health Business Corp. The 510(k) number is K241339.

When did Besmed Bacterial Filter and HMEF receive FDA 510(k) clearance?

Besmed Bacterial Filter and HMEF received FDA 510(k) clearance on 2024-11-14, under 510(k) number K241339.

Who is the listed applicant for Besmed Bacterial Filter and HMEF?

The FDA 510(k) record lists Besmed Health Business Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Besmed Bacterial Filter and HMEF?

The FDA product code for Besmed Bacterial Filter and HMEF is CAH.

Other records listing Besmed Health Business Corp as applicant

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.

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Related Devices (Code: CAH)

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.

K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® Exhalation FilterAmbu A/SK222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)Intersurgical , Ltd.K221472Filter and HME/FilterNingbo Huakun Medical Equipment Co., Ltd.

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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