FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
K Number: K051869
·
Decision Oct 7, 2005
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
70
Applicant Total
12
Review Days
88
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Basic Information
- Device Name
- NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
- K Number
- K051869
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Natus Medical, Inc.
- Date Received
- July 11, 2005
- Decision Date
- October 7, 2005
- 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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