Product code QTG

Device name

Infant Supine Sleep System

Medical specialty

General Hospital

Device class

2

Regulation number

880.5690

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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).

Source

FDA openFDA device classification dataset