TAS PTONE— 510(k) K955843

Substantially Equivalent

Cardiovascular Diagnostic Services

FDA 510(k) clearance K955843 for TAS PTONE, Substantially Equivalent on 1996-03-18. Applicant: Cardiovascular Diagnostic Services.

Clearance details

Applicant: Cardiovascular Diagnostic Services
Product code: Code GJS
Advisory panel: Hematology
Date received: 1995-12-26
Decision date: 1996-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

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.