FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AREMA II
K Number: K961129
·
Decision Apr 17, 1996
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
2
Review Days
27
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Basic Information
- Device Name
- AREMA II
- K Number
- K961129
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mellen Air Mfg., Inc.
- Date Received
- March 21, 1996
- Decision Date
- April 17, 1996
- 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
Other 510(k) clearances with the same product code (FNM), ordered by most recent decision date.
PRESSURE GUARD SITE SELECT (A)
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SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
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Other Clearances by Mellen Air Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963510 | APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM | Nov 26, 1996 | Substantially Equivalent |