PMP4 OXY PRO— 510(k) K043162

Substantially Equivalent

Card Guard Scientific Survival , Ltd.

FDA 510(k) clearance K043162 for PMP4 OXY PRO, Substantially Equivalent on 2004-12-29. Applicant: Card Guard Scientific Survival , Ltd..

Clearance details

Applicant: Card Guard Scientific Survival , Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2004-11-16
Decision date: 2004-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.