DATA MASTER PERFUSION MONITORING SYSTEM— 510(k) K001388

Substantially Equivalent

Dideco

FDA 510(k) clearance K001388 for DATA MASTER PERFUSION MONITORING SYSTEM, Substantially Equivalent on 2000-07-28. Applicant: Dideco.

Clearance details

Applicant: Dideco
Product code: Code DRY
Advisory panel: Cardiovascular
Date received: 2000-05-02
Decision date: 2000-07-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.