Switched Internal Paddles— 510(k) K203231

Substantially Equivalent

Philips North America, LLC

FDA 510(k) clearance K203231 for Switched Internal Paddles, Substantially Equivalent on 2021-01-11. Applicant: Philips North America, LLC.

Clearance details

Applicant: Philips North America, LLC
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 2020-11-02
Decision date: 2021-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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.