PORTABLE CARDIAC MONITOR, ABBY— 510(k) K760593

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K760593 for PORTABLE CARDIAC MONITOR, ABBY, Substantially Equivalent on 1976-09-16. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1976-09-07
Decision date: 1976-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.