FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BILIBED PHOTOTHERAPY LAMP
K Number: K962612
·
Decision Dec 12, 1996
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
70
Applicant Total
19
Review Days
162
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Basic Information
- Device Name
- BILIBED PHOTOTHERAPY LAMP
- K Number
- K962612
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medela, Inc.
- Date Received
- July 3, 1996
- Decision Date
- December 12, 1996
- 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 |
Similar 510(k) Clearances
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