FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INFANT PHOTOTHERAPY MASK
K Number: K851918
·
Decision Jun 7, 1985
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
4
Applicant Total
8
Review Days
36
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Basic Information
- Device Name
- INFANT PHOTOTHERAPY MASK
- K Number
- K851918
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5270
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Alba Health Care
- Date Received
- May 2, 1985
- Decision Date
- June 7, 1985
- Product Code
- FOK
- 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 |
|---|---|---|---|
| FOK | Pad, Neonatal Eye | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FOK), ordered by most recent decision date.
DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER
FDA 510(k)
FDA Class 1
·General Hospital
LIFE TRACE(R) BILIRUBIN MASK
FDA 510(k)
FDA Class 1
·General Hospital
PHOTO-THERAPY EYE PROTECTOR
FDA 510(k)
FDA Class 1
·General Hospital
INFANT PHOTOTHERAPY MASK
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Alba Health Care
| K Number | Device Name | ||
|---|---|---|---|
| K864689 | ALBA HEALTH CARE IODOFORM PACKING STRIP | Jan 20, 1987 | Substantially Equivalent |
| K861154 | ALBA HEALTH CARE PLAIN PACKING STRIP | Apr 15, 1986 | Substantially Equivalent |
| K850881 | ALBA DRY BURN PAD | Apr 17, 1985 | Substantially Equivalent |
| K850904 | ALBA DRY BURN DRESSING | Apr 17, 1985 | Substantially Equivalent |
| K850241 | ALBA HEALTH CARE NON-ADHERING DRESSING | Mar 12, 1985 | Substantially Equivalent |
| K812904 | STERILE ORTHOPEDIC STOCKINETTE | Jan 18, 1982 | Substantially Equivalent |
| K803171 | PROCEDURE & RECOVERY PATIENT SUIT | Mar 4, 1981 | Substantially Equivalent |