DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES— 510(k) K030417

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K030417 for DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES, Substantially Equivalent on 2003-05-09. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 2003-02-10
Decision date: 2003-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.