VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C— 510(k) K083820

Substantially Equivalent

Vasomedical, Inc.

FDA 510(k) clearance K083820 for VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C, Substantially Equivalent on 2009-04-01. Applicant: Vasomedical, Inc..

Clearance details

Applicant: Vasomedical, Inc.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2008-12-22
Decision date: 2009-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westbury, NY, 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.