Device |
infant supine sleep system |
Definition |
An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID). |
Product Code | QTG |
Regulation Number |
880.5690
|
Device Class |
2
|
MDR Year |
MDR Reports |
MDR Events |
2024 |
2 |
2 |
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