FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM
K Number: K882161
·
Decision Jul 12, 1988
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
6
Review Days
50
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Basic Information
- Device Name
- ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM
- K Number
- K882161
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ssi Medical Services, Inc.
- Date Received
- May 23, 1988
- Decision Date
- July 12, 1988
- 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 |
Similar 510(k) Clearances
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SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
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Other Clearances by Ssi Medical Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943385 | CLINITRON ELEXIS | Feb 27, 1995 | Substantially Equivalent |
| K942184 | CLINITRON AT HOME AIR FLUIDED THERAPY | Feb 7, 1995 | Substantially Equivalent |
| K914351 | CLINITRON C-10 | Feb 14, 1992 | Substantially Equivalent |
| K890523 | SUPERCAIR | Feb 10, 1989 | Substantially Equivalent |
| K863047 | FLEXICAIR | Sep 5, 1986 | Substantially Equivalent |