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

Name: FDA 510(k) clearance K902766
Creator: U.S. Food and Drug Administration
Published: 1991-03-12

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.. Device class: 2.

Clearance details

Applicant: Advanced Ischemia Recorders, Inc.
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
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 ↗

Recent devices under product code DSH

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K252389 — Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)2026-04-23
K253293 — VitaloJAK Clinic (Model 7100)2025-12-03
K243650 — Zio® monitor (DFG0001)2025-08-15
K243603 — AeviceMD2025-05-05

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.