FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIRTEC2 LOW AIR LOSS THERAPY BED
K Number: K970364
·
Decision Nov 17, 1997
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
56
Applicant Total
3
Review Days
290
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Basic Information
- Device Name
- AIRTEC2 LOW AIR LOSS THERAPY BED
- K Number
- K970364
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5170
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Apex Metal, Inc.
- Date Received
- January 31, 1997
- Decision Date
- November 17, 1997
- Product Code
- IOQ
- 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 |
|---|---|---|---|
| IOQ | Bed, Flotation Therapy, Powered | FDA class 2 | Physical Medicine |
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