FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DECUB-I-CON 800 AND 900 SYSTEM
K Number: K871614
·
Decision Aug 21, 1987
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
56
Applicant Total
1
Review Days
119
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Basic Information
- Device Name
- DECUB-I-CON 800 AND 900 SYSTEM
- K Number
- K871614
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5170
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Wholesale Medical Supply, Inc.
- Date Received
- April 24, 1987
- Decision Date
- August 21, 1987
- 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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