Little Angels Swaddling Blanket
FDA 510(k) K123411 · Bionix Development Corp.
510(k) numberK123411
Submission
- Device name
- Little Angels Swaddling Blanket
- Applicant
- Bionix Development Corp.
Toledo, OH, US - Received
- November 5, 2012
- Decision date
- March 7, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDH – Blanket, Neonatal Phototherapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5700
- Specialty
- General Hospital
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.
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Questions and answers
When was Little Angels Swaddling Blanket cleared by the FDA?
Little Angels Swaddling Blanket (K123411) received a 510(k) decision of Substantially Equivalent on March 7, 2013, 122 days after the submission was received.
What is the product code of K123411?
The FDA product code is PDH – Blanket, Neonatal Phototherapy, a Class II (moderate risk) device regulated under 21 CFR 880.5700.