FDA 510(k)

INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A

K-Number: K063747 · 2007-01-12

Decision Date2007-01-12

Product CodeMSH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A is the device name listed in this FDA 510(k) record. The listed applicant is Inovel, LLC. It received FDA 510(k) clearance on 2007-01-12 under 510(k) number K063747. 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 INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A?

INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A is a medical device that received FDA 510(k) clearance on 2007-01-12. The listed applicant is Inovel, LLC. The 510(k) number is K063747.

When did INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A receive FDA 510(k) clearance?

INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A received FDA 510(k) clearance on 2007-01-12, under 510(k) number K063747.

Who is the listed applicant for INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A?

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

What is the FDA product code for INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A?

The FDA product code for INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A is MSH.

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Other records listing Inovel, LLC as applicant

K062665INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS K061859INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS K051182INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS K042267INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.