FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GIRAFFE BLUE SPOT PT LITE
K Number: K120820
·
Decision Jun 8, 2012
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
70
Applicant Total
3
Review Days
81
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GIRAFFE BLUE SPOT PT LITE
- K Number
- K120820
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lumitex, Inc.
- Date Received
- March 19, 2012
- Decision Date
- June 8, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBI), ordered by most recent decision date.
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
FDA 510(k)
FDA Class 2
·General Hospital
BiliWrap
FDA 510(k)
FDA Class 2
·General Hospital
Infant Phototherapy Equipment
FDA 510(k)
FDA Class 2
·General Hospital
Neonatal Phototherapy System
FDA 510(k)
FDA Class 2
·General Hospital
bili-hut
FDA 510(k)
FDA Class 2
·General Hospital
neoBLUE blanket LED Phototherapy System
FDA 510(k)
FDA Class 2
·General Hospital