FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANESTHESIA FACE MASK
K Number: K953295
·
Decision Aug 11, 1995
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
50
Applicant Total
43
Review Days
28
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Basic Information
- Device Name
- ANESTHESIA FACE MASK
- K Number
- K953295
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5550
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mallinckrodt Medical
- Date Received
- July 14, 1995
- Decision Date
- August 11, 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 |
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| K955721 | CUFFED OROPHARYNGEAL AIRWAY (COPA) | Mar 28, 1997 | Substantially Equivalent |
| K965132 | HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES | Mar 20, 1997 | Substantially Equivalent |
| K962045 | ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT | Nov 26, 1996 | Substantially Equivalent |
| K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | Oct 4, 1996 | Substantially Equivalent |
| K955680 | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED | Mar 13, 1996 | Substantially Equivalent |