TELEPHONE DEFIBRILLATOR SYSTEM— 510(k) K864257

Name: FDA 510(k) clearance K864257
Creator: U.S. Food and Drug Administration
Published: 1987-11-27

Substantially Equivalent

Medphone Corp.

FDA 510(k) clearance K864257 for TELEPHONE DEFIBRILLATOR SYSTEM, Substantially Equivalent on 1987-11-27. Applicant: Medphone Corp.. Device class: 2.

Clearance details

Applicant: Medphone Corp.
Product code: Code LDD
Device class: Class 2
Regulation: 21 CFR 870.5300
Advisory panel: Cardiovascular
Date received: 1986-10-29
Decision date: 1987-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.