MODEL 456 ELECTROCARDIORECORDER RECORDER— 510(k) K863652

Name: FDA 510(k) clearance K863652
Creator: U.S. Food and Drug Administration
Published: 1986-12-10

Substantially Equivalent

Del Mar Avionics

FDA 510(k) clearance K863652 for MODEL 456 ELECTROCARDIORECORDER RECORDER, Substantially Equivalent on 1986-12-10. Applicant: Del Mar Avionics. Device class: 2.

Clearance details

Applicant: Del Mar Avionics
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1986-09-18
Decision date: 1986-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Del Mar Avionics

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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 DPS

product code DPS

Death: 7
Total: 7

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.