HEH · Chamber, Decompression, Abdominal
Obstetrics/Gynecology · 21 CFR 884.5225 · Class 3
Overview
| Product Code | HEH |
|---|---|
| Device Name | Chamber, Decompression, Abdominal |
| Regulation | 21 CFR 884.5225 |
| Device Class | Class 3 |
| Review Panel | Obstetrics/Gynecology |
Identification
An abdominal decompression chamber is a hoodlike device used to reduce pressure on the pregnant patient's abdomen for the relief of abdominal pain during pregnancy or labor.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
