FDA 510(k)

Master-Frank N95 Particulate Respirator

Numéro K : K172963 · 2018-04-04

DemandeurMaster & Frank Enterprise Co., Ltd.

Date de décision2018-04-04

Code produitMSH

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Master-Frank N95 Particulate Respirator is the device name listed in this FDA 510(k) record. The listed applicant is Master & Frank Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2018-04-04 under 510(k) number K172963. The device is classified under product code MSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Master-Frank N95 Particulate Respirator?

Master-Frank N95 Particulate Respirator is a medical device that received FDA 510(k) clearance on 2018-04-04. The listed applicant is Master & Frank Enterprise Co., Ltd.. The 510(k) number is K172963.

When did Master-Frank N95 Particulate Respirator receive FDA 510(k) clearance?

Master-Frank N95 Particulate Respirator received FDA 510(k) clearance on 2018-04-04, under 510(k) number K172963.

Who is the listed applicant for Master-Frank N95 Particulate Respirator?

The FDA 510(k) record lists Master & Frank Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Master-Frank N95 Particulate Respirator?

The FDA product code for Master-Frank N95 Particulate Respirator is MSH.

Essais cliniques associés

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Dispositifs connexes (Code : MSH)

K233022Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and SmallOwens & Minor (O&M) Halyard, Inc.K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S3M Healthcare K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd.

Source officielle

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