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FDA 510(k)

SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150

K-Number: K100139 · 2010-05-04

ApplicantSafelife Corp.
Decision Date2010-05-04
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 is the device name listed in this FDA 510(k) record. The listed applicant is Safelife Corp.. It received FDA 510(k) clearance on 2010-05-04 under 510(k) number K100139. 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 SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150?

SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 is a medical device that received FDA 510(k) clearance on 2010-05-04. The listed applicant is Safelife Corp.. The 510(k) number is K100139.

When did SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 receive FDA 510(k) clearance?

SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 received FDA 510(k) clearance on 2010-05-04, under 510(k) number K100139.

Who is the listed applicant for SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150?

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

What is the FDA product code for SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150?

The FDA product code for SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 is MSH.

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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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