FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR
K Number: K120244
·
Decision Jul 5, 2012
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
3
Review Days
160
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
- SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR
- K Number
- K120244
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nexera Medical, Inc.
- Date Received
- January 27, 2012
- Decision Date
- July 5, 2012
- Product Code
- ONT
- 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 |
|---|---|---|---|
| ONT | N95 Respirator With Antimicrobial/Antiviral Agent | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ONT), ordered by most recent decision date.
SpectraShield 9500 Surgical N95 Respirator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRASHIELD 9500 SURGICAL MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACTIPROTECT UF N95 RESPIRATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery