FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINITRON ELEXIS
K Number: K943385
·
Decision Feb 27, 1995
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
27
Applicant Total
6
Review Days
229
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Basic Information
- Device Name
- CLINITRON ELEXIS
- K Number
- K943385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5160
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ssi Medical Services, Inc.
- Date Received
- July 13, 1994
- Decision Date
- February 27, 1995
- Product Code
- INX
- 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 |
|---|---|---|---|
| INX | Bed, Air Fluidized | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (INX), ordered by most recent decision date.
HOME CARE BEAD BED
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CLINITRON RITE-HITE
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FDA Class 2
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CLINITRON AT HOME AIR FLUIDED THERAPY
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FDA Class 2
·Physical Medicine
X-20 AIR SUPPORT BED
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LOW AIR LOSS MATTRESS, MODIFICATION
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FDA Class 2
·Physical Medicine
DYLNAMEDICS A.S.A.P.
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Ssi Medical Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K882161 | ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM | Jul 12, 1988 | Substantially Equivalent |
| K863047 | FLEXICAIR | Sep 5, 1986 | Substantially Equivalent |