FDA 510(k)

GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR

K-Number: K050193 · 2005-04-11

Decision Date2005-04-11

Product CodeMSH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Louis M. Gerson Co., Inc.. It received FDA 510(k) clearance on 2005-04-11 under 510(k) number K050193. The device is classified under product code MSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR?

GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR is a medical device that received FDA 510(k) clearance on 2005-04-11. The listed applicant is Louis M. Gerson Co., Inc.. The 510(k) number is K050193.

When did GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR receive FDA 510(k) clearance?

GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR received FDA 510(k) clearance on 2005-04-11, under 510(k) number K050193.

Who is the listed applicant for GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR?

The FDA 510(k) record lists Louis M. Gerson Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR?

The FDA product code for GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR is MSH.

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Other records listing Louis M. Gerson Co., Inc. as applicant

K061375RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 K960778ISOLAIR APR TYPE N95 K925185ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS K931288ISOLAIR 2 FULL FACE SPLASH GUARD K922507GERSON ISOLAIR APR PARTICULATE SURGICAL MASK K881910LABELING CHANGE TO SURGICAL FACE MASK

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Related Devices (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.K172963Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd.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.K1210693M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK3M Company K102923BARRIER N95 PARTICULATE RESPIRATORMolnlycke Health Care

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.