DRK

Dc-Defibrillator, High Energy, (Including Paddles)

Product code

DRK

Device name

Dc-Defibrillator, High Energy, (Including Paddles)

Device class

Class 3

21 CFR

21 CFR 870.5300

Medical specialty

Cardiovascular

Marketing pathway

PMA

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

PMA to be filed by 12/26/96 (FR 50706 (9/27/96))

Definition text from the FDA device classification database (U.S. federal government work, public domain).