DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST— 510(k) K860470

Substantially Equivalent

Del Mar Avionics

FDA 510(k) clearance K860470 for DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST, Substantially Equivalent on 1986-04-30. Applicant: Del Mar Avionics.

Clearance details

Applicant: Del Mar Avionics
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1986-02-06
Decision date: 1986-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.