LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE— 510(k) K101331

Substantially Equivalent

C.R. Bard Inc., Bard Electrophysiology Division

FDA 510(k) clearance K101331 for LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE, Substantially Equivalent on 2010-10-08. Applicant: C.R. Bard Inc., Bard Electrophysiology Division.

Clearance details

Applicant: C.R. Bard Inc., Bard Electrophysiology Division
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2010-05-11
Decision date: 2010-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
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.