TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM— 510(k) K952659

Substantially Equivalent

Tronomed, Inc.

FDA 510(k) clearance K952659 for TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM, Substantially Equivalent on 1996-01-11. Applicant: Tronomed, Inc..

Clearance details

Applicant: Tronomed, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 1995-06-12
Decision date: 1996-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.