FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE CAROLINA ROCKER
K Number: K900839
·
Decision Apr 18, 1990
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
63
Applicant Total
7
Review Days
55
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Basic Information
- Device Name
- THE CAROLINA ROCKER
- K Number
- K900839
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3920
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Artec Environmental Monitoring Division
- Date Received
- February 22, 1990
- Decision Date
- April 18, 1990
- Product Code
- KNN
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| KNN | Components, Wheelchair | FDA class 1 | Physical Medicine |
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Other Clearances by Artec Environmental Monitoring Division
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K830056 | ARTEC TWIST VALVE | Mar 9, 1983 | Substantially Equivalent |