FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
K Number: K962123
·
Decision Jul 18, 1996
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
8
Review Days
48
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Basic Information
- Device Name
- AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
- K Number
- K962123
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lumex, Inc.
- Date Received
- May 31, 1996
- Decision Date
- July 18, 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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FDA Class 2
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MIGHTY AIR
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FDA Class 2
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ZAK-2000
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FDA Class 2
·General Hospital
PHYSIO/1000
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SIMPULSE
FDA 510(k)
FDA Class 2
·General Hospital
SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Lumex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963674 | LUMEX AIR | Jan 10, 1997 | Substantially Equivalent |
| K953675 | ALTADYNE | Sep 28, 1995 | Substantially Equivalent |
| K945175 | MECHANICAL WHEELCHAIR 890.3850 | May 12, 1995 | Substantially Equivalent |
| K945257 | 577ES (ERGOSENSE) | Apr 26, 1995 | Substantially Equivalent |
| K944574 | LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI) | Oct 17, 1994 | Substantially Equivalent |
| K923977 | AKROTECH 4000 | Feb 12, 1993 | Substantially Equivalent |
| K895740 | SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART | Feb 22, 1990 | Substantially Equivalent |