HRV 4000EM— 510(k) K932929

Substantially Equivalent

All-Tronics Medical Systems

FDA 510(k) clearance K932929 for HRV 4000EM, Substantially Equivalent on 1993-09-09. Applicant: All-Tronics Medical Systems.

Clearance details

Applicant: All-Tronics Medical Systems
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1993-06-15
Decision date: 1993-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, 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.