FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINITRON AIR FLUIDIZED SUPPORT J-101UD
K Number: K843389
·
Decision Sep 5, 1984
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
27
Applicant Total
3
Review Days
7
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Basic Information
- Device Name
- CLINITRON AIR FLUIDIZED SUPPORT J-101UD
- K Number
- K843389
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5160
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Uhi Corp.
- Date Received
- August 29, 1984
- Decision Date
- September 5, 1984
- 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 |
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