FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPAN-AID BRIDGING PILLOW SYSTEM
K Number: K801518
·
Decision Aug 4, 1980
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
56
Applicant Total
19
Review Days
34
Basic Information
- Device Name
- SPAN-AID BRIDGING PILLOW SYSTEM
- K Number
- K801518
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- SPAN-AMERICA MEDICAL SYSTEMS, INC.
- Date Received
- July 1, 1980
- Decision Date
- August 4, 1980
- Product Code
- HKX
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HKX | Tonometer, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by SPAN-AMERICA MEDICAL SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K973169 | PRESSURE GUARD SITE SELECT (A) | Feb 20, 1998 | Substantially Equivalent |
| K972486 | PRESSUREGUARD IV | Feb 20, 1998 | Substantially Equivalent |
| K960188 | PRESSUREGUARD: SELECTCARE | Oct 2, 1996 | Substantially Equivalent |
| K961502 | LUBRICATING JELLY, LOW VISCOSITY | Jul 18, 1996 | Substantially Equivalent |
| K961159 | POWERED LOW AIR LOSS MATTRESS SYSTEM | Jun 14, 1996 | Substantially Equivalent |
| K960620 | PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM | Apr 25, 1996 | Substantially Equivalent |
| K960189 | GEL-T CUSHION | Feb 7, 1996 | Substantially Equivalent |
| K954766 | PRESSURE GUARD ALTERNATING PRESSURE MATTRESS | Jan 11, 1996 | Substantially Equivalent |
| K953503 | PRESSUREGUARD IV | Oct 24, 1995 | Substantially Equivalent |
| K954117 | CUSTOMCARE SEATING SYSTEM | Oct 13, 1995 | Substantially Equivalent |