INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS— 510(k) K062665

Clearance details

Applicant

Inovel, LLC

Product code

Code MSH

Device class

Class 2

Regulation

21 CFR 878.4040

Advisory panel

General, Plastic Surgery

Date received

2006-09-07

Decision date

2006-10-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Culver City, CA, US

• K233022 — Halyard 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 Small2024-01-12
• K172963 — Master-Frank N95 Particulate Respirator2018-04-04
• K171116 — 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S2017-08-10
• K160271 — N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-122016-07-15
• K141876 — Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator2015-10-28

• K063747 — INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A2007-01-12
• K061859 — INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS2006-07-12
• K051182 — INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS2005-05-19
• K042267 — INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP2004-09-30