FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NANOBLUTM 500
K Number: K113206
·
Decision Feb 17, 2012
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
69
Applicant Total
47
Review Days
108
Basic Information
- Device Name
- NANOBLUTM 500
- K Number
- K113206
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Draeger Medical Systems, Inc.
- Date Received
- November 1, 2011
- Decision Date
- February 17, 2012
- 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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