VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY— 510(k) K111180

Substantially Equivalent

Vasomedical, Inc.

FDA 510(k) clearance K111180 for VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY, Substantially Equivalent on 2011-06-28. Applicant: Vasomedical, Inc..

Clearance details

Applicant: Vasomedical, Inc.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2011-04-27
Decision date: 2011-06-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Westbury, NY, US

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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.