FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION
K Number: K945667
·
Decision Feb 21, 1995
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
28
Applicant Total
3
Review Days
96
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Basic Information
- Device Name
- MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION
- K Number
- K945667
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3175
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Micos Medical Systems
- Date Received
- November 17, 1994
- Decision Date
- February 21, 1995
- Product Code
- KIC
- 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 |
|---|---|---|---|
| KIC | Cushion, Flotation | FDA class 1 | Physical Medicine |
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