MODEL 459 ELECTROCARDIOCORDER RECORDER— 510(k) K884009

Name: FDA 510(k) clearance K884009
Creator: U.S. Food and Drug Administration
Published: 1988-11-09

Substantially Equivalent

Del Mar Avionics

FDA 510(k) clearance K884009 for MODEL 459 ELECTROCARDIOCORDER RECORDER, Substantially Equivalent on 1988-11-09. Applicant: Del Mar Avionics. Device class: 2.

Clearance details

Applicant: Del Mar Avionics
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1988-09-21
Decision date: 1988-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K990027 — OMNICORDER, MODEL 4641999-02-09
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K963174 — HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)1997-03-13
K950020 — HOLTER PACERCORDER(R)1995-08-17
K942653 — HOLTER SSR DIGICORDER(TM)1995-05-10

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.