Product code GZE

Device name
Implanted Diaphragmatic/Phrenic Nerve Stimulator
Medical specialty
Neurology
Device class
3
Regulation number
882.5830
Review panel
AN
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86
Source
FDA openFDA device classification dataset