SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL— 510(k) K053248

Substantially Equivalent

Electromed, Inc.

FDA 510(k) clearance K053248 for SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL, Substantially Equivalent on 2005-12-01. Applicant: Electromed, Inc..

Clearance details

Applicant: Electromed, Inc.
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 2005-11-21
Decision date: 2005-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahtomedi, MN, US

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Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.