PAGEWRITER TC 20, 30, 50, 70— 510(k) K113144

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K113144 for PAGEWRITER TC 20, 30, 50, 70, Substantially Equivalent on 2012-04-03. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2011-10-25
Decision date: 2012-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.