FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SWEEN UNIVERSAL BED RAIL PADS
K Number: K810846
·
Decision Apr 17, 1981
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
38
Applicant Total
4
Review Days
21
Basic Information
- Device Name
- SWEEN UNIVERSAL BED RAIL PADS
- K Number
- K810846
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5120
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- SWEEN CORP.
- Date Received
- March 27, 1981
- Decision Date
- April 17, 1981
- Product Code
- FNJ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FNJ | Bed, Manual | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FNJ), ordered by most recent decision date.
KING KRIB
FDA 510(k)
FDA Class 1
·General Hospital
CRADLE, HOSPITAL BED CLOTHING
FDA 510(k)
FDA Class 1
·General Hospital
BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT
FDA 510(k)
FDA Class 1
·General Hospital
SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED
FDA 510(k)
FDA Class 1
·General Hospital
ENVIROTENT (BED)
FDA 510(k)
FDA Class 1
·General Hospital
MSI STANDARD BED MODELS: L1097-64 AND L1085-64
FDA 510(k)
FDA Class 1
·General Hospital