PDH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Blanket, Neonatal Phototherapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5700
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
- FDA definition
- Is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Luma Wrap (K142416) | Salter Labs | 2015-06-12 |
| LITTLE ANGELS SWADDLING BLANKET (K123411) | Bionix Development Corp. | 2013-03-07 |
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