FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFANT PHOTOTHERAPY LIGHT
K Number: K813188
·
Decision Dec 9, 1981
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
70
Applicant Total
2
Review Days
23
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Basic Information
- Device Name
- INFANT PHOTOTHERAPY LIGHT
- K Number
- K813188
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Montrose Phototherapy Supply
- Date Received
- November 16, 1981
- Decision Date
- December 9, 1981
- Product Code
- LBI
- 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 |
|---|---|---|---|
| LBI | Unit, Neonatal Phototherapy | FDA class 2 | General Hospital |
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Other Clearances by Montrose Phototherapy Supply
| K Number | Device Name | ||
|---|---|---|---|
| K813214 | INFANT PHOTOTHERAPY MASK | Dec 9, 1981 | Substantially Equivalent |