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FDA 510(k)

N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C

K-Number: K070168 · 2007-04-18

ApplicantAearo Company
Decision Date2007-04-18
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C is the device name listed in this FDA 510(k) record. The listed applicant is Aearo Company. It received FDA 510(k) clearance on 2007-04-18 under 510(k) number K070168. 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 N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C?

N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C is a medical device that received FDA 510(k) clearance on 2007-04-18. The listed applicant is Aearo Company. The 510(k) number is K070168.

When did N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C receive FDA 510(k) clearance?

N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C received FDA 510(k) clearance on 2007-04-18, under 510(k) number K070168.

Who is the listed applicant for N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C?

The FDA 510(k) record lists Aearo Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C?

The FDA product code for N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C is MSH.

Related Clinical Trials

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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Other records listing Aearo Company 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.

K072359AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511CK063013PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S

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

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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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