FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C
K Number: K070168
·
Decision Apr 18, 2007
Classifications
1
FEI Numbers
224
Registration Numbers
224
Same Product Code
34
Applicant Total
3
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C
- K Number
- K070168
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aearo Company
- Date Received
- January 18, 2007
- Decision Date
- April 18, 2007
- Product Code
- MSH
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MSH | Respirator, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSH), ordered by most recent decision date.
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 Small
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Master-Frank N95 Particulate Respirator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 Respirator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery