FDA.reportPublic FDA data

Product code DRK

Device name
Dc-Defibrillator, High Energy, (Including Paddles)
Medical specialty
Cardiovascular
Device class
3
Regulation number
870.5300
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
PMA to be filed by 12/26/96 (FR 50706 (9/27/96))
Source
FDA openFDA device classification dataset