DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.— 510(k) K894355

Substantially Equivalent

Phycon

FDA 510(k) clearance K894355 for DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT., Substantially Equivalent on 1989-12-12. Applicant: Phycon.

Clearance details

Applicant: Phycon
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1989-07-14
Decision date: 1989-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

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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.