CARDIO DATA PACERECORDER PR3— 510(k) K853262

Substantially Equivalent

Cardio Data

FDA 510(k) clearance K853262 for CARDIO DATA PACERECORDER PR3, Substantially Equivalent on 1985-10-11. Applicant: Cardio Data.

Clearance details

Applicant: Cardio Data
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1985-08-05
Decision date: 1985-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.