FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE ADHESIVE FACE MASK
K Number: K950771
·
Decision Mar 10, 1995
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
50
Applicant Total
3
Review Days
382
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
- DISPOSABLE ADHESIVE FACE MASK
- K Number
- K950771
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5550
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Advanced Warming Systems, Inc.
- Date Received
- February 21, 1994
- Decision Date
- March 10, 1995
- Product Code
- BSJ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSJ | Mask, Gas, Anesthetic | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSJ), ordered by most recent decision date.
SuperNO2VA Device
FDA 510(k)
FDA Class 1
·Anesthesiology
ANESTHESIA/RESPIRATORY FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
ANESTHESIA FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
MASK, GAS, ANESTHETIC
FDA 510(k)
FDA Class 1
·Anesthesiology