CARDIOGUARD STRESS TEST MONITOR 4002— 510(k) K850043

Name: FDA 510(k) clearance K850043
Creator: U.S. Food and Drug Administration
Published: 1985-02-08

Substantially Equivalent

Del Mar Avionics

FDA 510(k) clearance K850043 for CARDIOGUARD STRESS TEST MONITOR 4002, Substantially Equivalent on 1985-02-08. Applicant: Del Mar Avionics. Device class: 2.

Clearance details

Applicant: Del Mar Avionics
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1985-01-07
Decision date: 1985-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K950020 — HOLTER PACERCORDER(R)1995-08-17
K942653 — HOLTER SSR DIGICORDER(TM)1995-05-10

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.