FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTEC RESPOND PULMONARY RESUSCITATOR
K Number: K896886
·
Decision Feb 6, 1990
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
7
Review Days
60
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Basic Information
- Device Name
- ARTEC RESPOND PULMONARY RESUSCITATOR
- K Number
- K896886
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Artec Environmental Monitoring Division
- Date Received
- December 8, 1989
- Decision Date
- February 6, 1990
- Product Code
- BTM
- 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | FDA class 2 | 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 |
| 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 |
| K830056 | ARTEC TWIST VALVE | Mar 9, 1983 | Substantially Equivalent |