DIASCOPE TRAVELLER PLUS (4053)— 510(k) K964593

Name: FDA 510(k) clearance K964593
Creator: U.S. Food and Drug Administration
Published: 1997-06-30

Substantially Equivalent

S & W Medico Teknik A/S

FDA 510(k) clearance K964593 for DIASCOPE TRAVELLER PLUS (4053), Substantially Equivalent on 1997-06-30. Applicant: S & W Medico Teknik A/S. Device class: 2.

Clearance details

Applicant: S & W Medico Teknik A/S
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1996-11-15
Decision date: 1997-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albertslund, DK

Download summary PDF View on FDA.gov ↗

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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.