ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE— 510(k) K902766

Substantially Equivalent

Advanced Ischemia Recorders, Inc.

FDA 510(k) clearance K902766 for ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE, Substantially Equivalent on 1991-03-12. Applicant: Advanced Ischemia Recorders, Inc..

Clearance details

Applicant: Advanced Ischemia Recorders, Inc.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1990-06-21
Decision date: 1991-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Desert, CA, 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.