CARDIORATER CR7— 510(k) K852910

Name: FDA 510(k) clearance K852910
Creator: U.S. Food and Drug Administration
Published: 1985-11-19

Substantially Equivalent

Cardiac Recorders, Ltd.

FDA 510(k) clearance K852910 for CARDIORATER CR7, Substantially Equivalent on 1985-11-19. Applicant: Cardiac Recorders, Ltd.. Device class: 2.

Clearance details

Applicant: Cardiac Recorders, Ltd.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1985-07-09
Decision date: 1985-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Cardiac Recorders, Ltd.

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K864704 — CARDIAN III CR6A1987-03-20
K861621 — CARDIAN II CR45A1986-09-12
K853673 — CARDIORATER CR 511985-12-11
K852887 — CR5 CARDIAC MONITOR1985-11-14
K852905 — CR 280/45, CR281/4 DEFIBRILLATOR1985-11-05

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.