FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADD-ON TO CRITICAL PATIENT CARE BED
K Number: K882177
·
Decision Dec 1, 1988
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
56
Applicant Total
9
Review Days
191
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Basic Information
- Device Name
- ADD-ON TO CRITICAL PATIENT CARE BED
- K Number
- K882177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5170
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Cardio Systems, Inc.
- Date Received
- May 24, 1988
- Decision Date
- December 1, 1988
- 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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|---|---|---|---|
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| K934689 | LOW AIR LOSS MATTRESS, MODIFICATION | Feb 2, 1994 | Substantially Equivalent |
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| K852736 | BAYLOR RAPID AUTOTRANSFUSION SYSTEM | Sep 18, 1985 | Substantially Equivalent |
| K792152 | CARDIOPLEGIA SOLUTION ADMIN. SET | Nov 13, 1979 | Substantially Equivalent |
| K792151 | OXYGENATOR GAS LINE FILTER | Nov 13, 1979 | Substantially Equivalent |