FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ARTEC TWIST VALVE
K Number: K830056
·
Decision Mar 9, 1983
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
18
Applicant Total
7
Review Days
62
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Basic Information
- Device Name
- ARTEC TWIST VALVE
- K Number
- K830056
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5320
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Artec Environmental Monitoring Division
- Date Received
- January 6, 1983
- Decision Date
- March 9, 1983
- Product Code
- BTC
- 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 |
|---|---|---|---|
| BTC | Bag, Reservoir | FDA class 1 | Anesthesiology |
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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 |
| K832512 | AIRWAY MASKS | Jan 17, 1984 | Substantially Equivalent |