VITELCARE TURTLE, MODEL 400— 510(k) K043368

Substantially Equivalent

Visual Telecommunications Network, Inc.

FDA 510(k) clearance K043368 for VITELCARE TURTLE, MODEL 400, Substantially Equivalent on 2005-02-01. Applicant: Visual Telecommunications Network, Inc..

Clearance details

Applicant: Visual Telecommunications Network, Inc.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2004-12-08
Decision date: 2005-02-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Mclean, VA, US

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Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.