Product code DRK— Cardiovascular

POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10

Classification name: Dc-Defibrillator, High Energy, (Including Paddles)
Device class: Class 3
Regulation: 21 CFR 870.5300
Advisory panel: Cardiovascular
Total cleared: 1
First cleared: 1993-10-07
Most recent: 1993-10-07

FDA classification definition

“PMA to be filed by 12/26/96 (FR 50706 (9/27/96))”
— U.S. Food and Drug Administration, device classification record for product code DRK under 21 CFR 870.5300, via openFDA

Market context for product code DRK

FDA has cleared 1 device under product code DRK, all in 1993, filed by 1 applicant company. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.

Top applicants under product code DRK

National Custom Ent., Inc.1 clearance

Recent clearances under product code DRK

K934067 — POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10National Custom Ent., Inc.·1993-10-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.