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FDA 510(k)

ISOLAIR APR TYPE N95

K-Number: K960778 · 1996-05-09

ApplicantLouis M. Gerson Co., Inc.
Decision Date1996-05-09
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOLAIR APR TYPE N95 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 1996-05-09 under 510(k) number K960778. 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 ISOLAIR APR TYPE N95?

ISOLAIR APR TYPE N95 is a medical device that received FDA 510(k) clearance on 1996-05-09. The listed applicant is Louis M. Gerson Co., Inc.. The 510(k) number is K960778.

When did ISOLAIR APR TYPE N95 receive FDA 510(k) clearance?

ISOLAIR APR TYPE N95 received FDA 510(k) clearance on 1996-05-09, under 510(k) number K960778.

Who is the listed applicant for ISOLAIR APR TYPE N95?

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 ISOLAIR APR TYPE N95?

The FDA product code for ISOLAIR APR TYPE N95 is MSH.

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

K061375RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730K050193GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATORK925185ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MASK931288ISOLAIR 2 FULL FACE SPLASH GUARDK922507GERSON ISOLAIR APR PARTICULATE SURGICAL MASKK881910LABELING CHANGE TO SURGICAL FACE MASK

View all 8 devices →

Related Devices (Code: MSH)

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.

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 HealthcareK160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd.K1210693M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK3M CompanyK102923BARRIER 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.

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