510(k) K142416
- Device
- Luma Wrap
- Applicant
- Salter Labs
- 510(k) number
- K142416
- Product code
- PDH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-06-12
- Date received
- 2014-08-28
- Regulation
- 880.5700
- Classification name
- Blanket, Neonatal Phototherapy
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Aurelia Browndridge
- Address
- 2365 Camino Vida Roble Carlsbad CA US 92011 92011
FDA Registration Numbers#
- 3010272829
- 3023339256
- 3004748541
- 1066270
Source Documents#
Other 510(k) Records For Product Code PDH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123411 | LITTLE ANGELS SWADDLING BLANKET | Bionix Development Corp. | 2013-03-07 |
Legacy Summary#
summary
FDA Review#
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