510(k) K123411
- Device
- LITTLE ANGELS SWADDLING BLANKET
- Applicant
- BIONIX DEVELOPMENT CORP.
- 510(k) number
- K123411
- Product code
- PDH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-03-07
- Date received
- 2012-11-05
- 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
- JAMES HUTTNER
- Address
- 5154 Enterprise Blvd. Toledo OH US 43612 43612
FDA Registration Numbers#
- 3010272829
- 1066270
- 3004748541
- 3023339256
Source Documents#
Other 510(k) Records For Product Code PDH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142416 | Luma Wrap | Salter Labs | 2015-06-12 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases