FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BEDDING PADS EGGCREATE PADS
K Number: K802781
·
Decision Dec 10, 1980
Classifications
1
FEI Numbers
154
Registration Numbers
154
Same Product Code
7
Applicant Total
1
Review Days
35
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BEDDING PADS EGGCREATE PADS
- K Number
- K802781
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5150
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Leemart Bedding Mfg. Co.
- Date Received
- November 5, 1980
- Decision Date
- December 10, 1980
- Product Code
- IKY
- 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 |
|---|---|---|---|
| IKY | Mattress, Flotation Therapy, Non-Powered | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IKY), ordered by most recent decision date.
SCM-3 AND ACCESSORIES
FDA 510(k)
FDA Class 1
·General Hospital
GEL FLOTATION MATTRESS
FDA 510(k)
FDA Class 1
·General Hospital
TETRA NATAL-MAT WATER FLOTATION MAT.
FDA 510(k)
FDA Class 1
·General Hospital
ECONO-FLOAT WATER FLOTATION MATTRESS
FDA 510(k)
FDA Class 1
·General Hospital
NEONATAL FLOTATION SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
MEDPRO FLOTATION SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital