BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500— 510(k) K141795

Substantially Equivalent

R & D Batteries, Inc.

FDA 510(k) clearance K141795 for BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500, Substantially Equivalent on 2014-12-08. Applicant: R & D Batteries, Inc..

Clearance details

Applicant: R & D Batteries, Inc.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2014-07-03
Decision date: 2014-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castle Rock, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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