CARDIOCASSETTE II, AMBULATORY ECG SYSTEM— 510(k) K790509

Name: FDA 510(k) clearance K790509
Creator: U.S. Food and Drug Administration
Published: 1979-03-23

Substantially Equivalent

Cambridge Instruments, Inc.

FDA 510(k) clearance K790509 for CARDIOCASSETTE II, AMBULATORY ECG SYSTEM, Substantially Equivalent on 1979-03-23. Applicant: Cambridge Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Cambridge Instruments, Inc.
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1979-03-15
Decision date: 1979-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K243603 — AeviceMD2025-05-05

More clearances from Cambridge Instruments, Inc.

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K803229 — 4-CHANNEL ECG TELEMETRY MON. SYST. #30451981-01-13
K801224 — CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM1980-06-26
K800566 — CAMBRIDGE VS-550 ELECTROCARDIOGRAPH1980-04-08

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.