FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMERICAN AIRCARE SYSTEM
K Number: K811684
·
Decision Jul 2, 1981
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
3
Review Days
17
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Basic Information
- Device Name
- AMERICAN AIRCARE SYSTEM
- K Number
- K811684
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- American Hamilton
- Date Received
- June 15, 1981
- Decision Date
- July 2, 1981
- Product Code
- FNM
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | FDA class 2 | General Hospital |
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