FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Luma Wrap
K Number: K142416
·
Decision Jun 12, 2015
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
1
Applicant Total
48
Review Days
288
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Basic Information
- Device Name
- Luma Wrap
- K Number
- K142416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Salter Labs
- Date Received
- August 28, 2014
- Decision Date
- June 12, 2015
- Product Code
- PDH
- 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 |
|---|---|---|---|
| PDH | Blanket, Neonatal Phototherapy | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PDH), ordered by most recent decision date.
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