FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AIRWAY MASKS
K Number: K832512
·
Decision Jan 17, 1984
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
7
Review Days
174
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Basic Information
- Device Name
- AIRWAY MASKS
- K Number
- K832512
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Artec Environmental Monitoring Division
- Date Received
- July 27, 1983
- Decision Date
- January 17, 1984
- Product Code
- CAE
- 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 |
|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAE), ordered by most recent decision date.
LMA FAMILY OF AIRWAYS
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KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
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KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
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KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
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CUFFED OROPHARYNGEAL AIRWAY (COPA)
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RUSCH OPTOSAFE
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Other Clearances by Artec Environmental Monitoring Division
| K Number | Device Name | ||
|---|---|---|---|
| K900839 | THE CAROLINA ROCKER | Apr 18, 1990 | Substantially Equivalent |
| K896886 | ARTEC RESPOND PULMONARY RESUSCITATOR | Feb 6, 1990 | Substantially Equivalent |
| K873043 | MOUTH TO FACE RESUSCITATOR | Sep 28, 1987 | Substantially Equivalent |
| K863910 | RAINCOAT | Oct 20, 1986 | Substantially Equivalent |
| K854573 | ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE | Jan 3, 1986 | Substantially Equivalent |
| K830056 | ARTEC TWIST VALVE | Mar 9, 1983 | Substantially Equivalent |