CPR RSQ ASSIST— 510(k) K123248

Substantially Equivalent

Avantech, Inc.

FDA 510(k) clearance K123248 for CPR RSQ ASSIST, Substantially Equivalent on 2013-12-10. Applicant: Avantech, Inc..

Clearance details

Applicant: Avantech, Inc.
Product code: Code LIX
Advisory panel: Cardiovascular
Date received: 2012-10-17
Decision date: 2013-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philedelphia, PA, US

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Adverse events under product code LIX

product code LIX

Other: 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.