V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM— 510(k) K141185

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K141185 for V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM, Substantially Equivalent on 2014-06-06. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2014-05-07
Decision date: 2014-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Lowell, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.