FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROAIR FLUIDIZED AIR BED
K Number: K884529
·
Decision Nov 18, 1988
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
27
Applicant Total
4
Review Days
21
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Basic Information
- Device Name
- MICROAIR FLUIDIZED AIR BED
- K Number
- K884529
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5160
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Gsi Development Co.
- Date Received
- October 28, 1988
- Decision Date
- November 18, 1988
- 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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