NEONATAL RESTRAINT AND COMFORT SYSTEMS
Device Facts
| Record ID | K943017 |
|---|---|
| Device Name | NEONATAL RESTRAINT AND COMFORT SYSTEMS |
| Applicant | K.Bowmed, Inc. |
| Product Code | FRP · General Hospital |
| Decision Date | Jan 19, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5680 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A pediatric position holder is a device used to hold an infant or a child in a desired position for therapeutic or diagnostic purposes, e.g., in a crib under a radiant warmer, or to restrain a child while an intravascular injection is administered.
